Process for enrobing a core

ABSTRACT

A process for enrobing a core, such as a tablet core, uses a coating that is made of a patterned film having portions that are visually distinct (.e.g, differently colored) from one another and having a transition line segment between these visually distinct portions. At least a portion of an outer surface of the core is covered with the film, such that the transition line segment forms a substantially continuous transition line on the coating and such that a film seam is formed which is different from the transition line. Alternatively, the coating is formed from two such patterned films, in which case the outer surface of the core is covered with the two films such that the two transition line segments cooperate to form a substantially continuous transition line on the coating and a film seam is formed which is different from the transition line. Prior to covering the outer surface of the core, the two films may be oriented such that the resulting enrobed core has a bi-colored coating with two visually distinct portions each lying on opposite sides of the transition line of the coating. The two films may also be oriented such that the resulting enrobed core has four alternately arranged colored portions, two of which are of a first color and the other two of which are of a second color, thereby resulting in a “checkerboard” effect.

FIELD OF THE INVENTION

[0001] The present invention relates to a process for enrobing a core,such as a tablet core, with at least one patterned film to produce anenrobed core having a patterned coating.

BACKGROUND OF THE INVENTION

[0002] Various oral dosage forms have been developed over the years forpharmaceuticals and dietary supplements. Among the more popular oraldosage forms are tablets, capsules and, most recently, gelcaps. Tabletsare compressed or molded solid dosage forms of any size or shape. Solid,generally oblong-shaped tablets may sometimes be referred to as caplets.Tablets remain popular with consumers, however uncoated tablets sufferfrom drawbacks such as medicinal taste, a tendency to powder or flake(i.e., physical disintegration) when packaged in bottles, and/or theperception by consumers that they are not easy to swallow. Theselimitations are eliminated by coating the tablets with a polymericcoating.

[0003] During most of the 20th century, hard gelatin capsules were apopular dosage form for prescription and over-the-counter (OTC) drugs.Capsules are hard shell compartments made of two halves, including abody and a cap, wherein the cap partially and snugly overlaps with thebody to enclose a dosable drug ingredient therein. The enclosed dosableingredient is most often is a powder, liquid, paste or similar nonsolidform.

[0004] Generally, empty hard shell capsules are produced by aconventional dip-molding process such as that which is described on page182 of “Pharmaceutical Dosage Forms and Drug Delivery Systems, 7^(th)Ed.”, (1999) by Howard C. Ansel, Loyd V. Allen Jr., and Nicholas G.Popovich, published by Lippincott Williams & Wilkins, Baltimore, Md.Consumers have found that such capsules are aesthetically pleasing, easyto swallow and mask the medicine taste of the drug contained therein. Inaddition, the bodies and caps of such capsules are often produced indifferent colors, resulting in a bi-colored capsule product havingenhanced aesthetic appeal, as well as improved product identificationand brand recognition by consumers. Many patients preferred capsulesover coated or uncoated tablets, prompting pharmaceutical manufacturersto market certain products in capsule form even when they were alsoavailable in tablet form. However, due to potential tampering concerns,capsules are no longer a preferred delivery choice for consumer (i.e.,over-the-counter) pharmaceuticals.

[0005] One alternative to capsule products are caplets, which are solid,oblong tablets that are often coated with various polymers such ascellulose ethers to improve their aesthetics, stability, andswallowability. Typically, such polymers are applied to the tabletseither from solution in organic solvents, or from aqueous dispersion viaspraying. Still other methods involve spray coating tablets with agelatin coating solution. See, e.g., U.S. Pat. Nos. 4,973,480 and6,113,945. However, such spray-coated tablets lack the glossy surfaceand elegance of the hard gelatin capsules. Additionally, it is notcommercially feasible to spray-coat a tablet with a different colorcoating on each end.

[0006] Another alternative to capsule products are “gelcaps,” which areelegant, consumer-preferred dosage forms comprising solid tabletscovered with a glossy gelatinous coating. Currently, gelcaps are amongthe most popular oral dosage forms. Several methods of producing gelcapshave been developed in an effort to provide tamper-proof capsule-likeproducts. One category of such methods involve dipping tablets, one halfat a time, into gelatin coating solutions, which can be of two differentcolors, see, e.g., U.S. Pat. No. 4,820,524, or dipping tablets of afirst color halfway into a into gelatin coating solution of a secondcolor, see, e.g., U.S. Pat. No. 6,113,945. Another category of suchmethods involves shrink-fitting the capsule halves onto a tablet form.See, for example, U.S. Pat. Nos. 5,415,868, 6,126,767, 5,464,631,5,460,824, 5,317,849, 5,511,361, 5,609,010, 5,795,588 and 6,080,426, andInternational Patent Appln. Publication No. WO 97/37629. Another methodinvolves sealing the body and cap of the capsule at the overlapping seamtherebetween. See U.S. Pat. No. 5,824,338. Another method of producinggelcaps is via an enrobing process wherein two separate films made ofgelatinous material are applied to opposite sides of a tablet by a pairof rotary dies. A detailed description of this process is provided, forexample, in U.S. Pat. Nos. 5,146,730 and 5,459,983, and the entirecontents and disclosures of both of these patents are herebyincorporated herein by reference.

[0007] Briefly, in the aforesaid rotary die process, two circular dieseach having a circumferential surface are positioned such that thesurfaces are in abutting relationship with one another, thereby forminga nip therebetween. Each of the dies have a series of matching recesseson their circumferential surfaces. As the dies rotate, the films arejoined and fused together, at the nip between the dies where a pair ofmatching recesses form a pocket into which a tablet is dropped by ametered feed mechanism. As the dies continue to rotate, the tablet urgesthe films into the interior of the recesses in the dies, and the tabletis thereby securely enveloped and enrobed by the films, while the filmscontinue to be joined and fused together about the tablet by the dies.Simultaneously with the fusing of the films about the tablet, theenrobed tablet is pinch-cut from the films by the rotary dies, whereuponit separates from the films in the form of an individual enrobed tablet.If the films used are of two different colors, the resulting enrobedtablets are bi-colored having a color transition line that iscommensurate with the seam between the films. Thus, while foregoingprocess produces tamper-proof bi-colored enrobed tablets, the colortransition of such products will always be commensurate with the seambetween the films.

[0008] Each of the foregoing methods for producing tamper-proof coatedtablets suffer from several shortcomings, including uneven color of thecapsule halves and/or coatings, uneven thickness of the capsule halvesand/or coatings, and the creation of raised seams between capsule halvesand/or coatings. In addition, the bi-colored products resulting from theaforesaid methods have a line defined by the color transition, which isalways the same as the line defined by the seam between the capsulehalves and/or coatings.

[0009] U.S. Pat. No. 5,672,300 discloses the production and use ofstriped and patterned films with the foregoing rotary die process toproduce patterned enrobed tablets. The striped films disclosed thereinare produced by depositing stock film forming material of a first colorfrom a first spreader box to form a base film and then, using a secondspreader box, adding stripes of a differently colored stock materialonto the base film. Films having different patterns, including stripesand/or marbleized, are created by oscillating the second spreader boxrelative to the first spreader box. The gelcaps produced by this processhave multiple stripes, or a marbleized pattern, rather than simply beingbi-colored (i.e., one half being one color and the other half being asecond color). Films prepared by this process suffer from the limitationof having multiple layers, with increased total film thickness in thearea where the second film material is applied. The increased filmthickness creates an uneven appearance and feel to the surface, andretards dissolution, which is undesirable for immediate release dosageforms. Thus, there is still a need to produce bi-colored enrobed tabletsthat are enrobed with films according to the rotary die process and thathave color transitions that are not commensurate with the seam betweenthe films.

SUMMARY OF THE INVENTION

[0010] The present invention relates to a process for enrobing a core,such as a tablet core, using a coating that is made of a patterned filmhaving portions that are visually distinct (e.g., differently colored)from one another and having a transition line segment between suchvisually distinct portions. More particularly, at least a portion of anouter surface of the core is covered with the patterned film, such thatthe transition line segment forms a substantially continuous transitionline on the coating and such that a film seam is formed which isdifferent from the transition line. That is, the film seam liessubstantially in a first reference plane that passes through the core,while the transition line segment lies substantially in a secondreference plane that passes through the core and intersects the firstreference plane.

[0011] Alternatively, the coating is formed from two films, each ofwhich has portions that are visually distinct from one another and atransition line segment between such visually distinct portions. Theouter surface of the core is covered with the two films such that thetwo transition line segments cooperate to form a substantiallycontinuous transition line on the coating and a film seam is formed onthe coating which is different from the transition line. Like when asingle film is used, the film seam lies substantially in the firstreference plane that passes through the core, while the transition linesegment lies substantially in the second reference plane that passesthrough the core and intersects the first reference plane.

[0012] By using bi-colored films and orienting the films appropriatelywith reference to the core and each other, the resulting enrobed corecan be bi-colored with the film seam of the coating lying substantiallyin the first reference plane and the transition line between the twocolors thereof lying substantially in the second reference plane. Inaddition, the resulting enrobed core can instead have four alternatelyarranged colored portions, two of which are of a first color and theother two of which are of a second color, thereby resulting in a“checkerboard” effect.

[0013] Where the portions of each of the two films are all visuallydistinct from one another and the films are properly oriented withreference to the core and each other, the resulting enrobed core canhave a coating with at least four portions each having a differentvisual distinction (e.g., color). The film seam of the coating wouldstill lie substantially in the first reference plane and the transitionline would still be different from the film seam and would still liesubstantially in the second reference plane.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] For a better understanding of the present invention, reference ismade to the following detailed description of several exemplaryembodiments considered in conjunction with the accompanying drawings, inwhich:

[0015]FIG. 1A is an enlarged, schematic top plan view of an oblongconvex core of a first configuration, the bottom plan view beingidentical thereto;

[0016]FIG. 1B is an enlarged, schematic elevational side view of theoblong convex core of FIG. 1A, the opposite elevational side view beingidentical thereto;

[0017]FIG. 2 is an enlarged, schematic elevational end view of theoblong convex core of FIGS. 1A and 1B, the opposite elevational end viewbeing identical thereto;

[0018]FIG. 3 is an enlarged, schematic elevational side view of anoblong convex core of a second configuration, the opposite elevationalside view, as well as the top and bottom plan views, being identicalthereto;

[0019]FIG. 4 is an enlarged, schematic elevational end view of theoblong convex core of FIG. 3, the opposite elevational end view beingidentical thereto;

[0020]FIG. 5 is an enlarged, schematic top plan view of a round convexcore, the bottom plan view being identical thereto;

[0021]FIG. 6 is an enlarged, schematic elevational front view of theround convex core of FIG. 5, the elevational back view, as well as bothelevational side views, being identical thereto;

[0022]FIG. 7A is an enlarged, schematic top plan view of a round flatcore with beveled edges, the schematic bottom plan view being identicalthereto;

[0023]FIG. 7B is an enlarged, schematic elevational front view of theround flat core of FIG. 7A, the elevational back view, as well as bothelevational side views, being identical thereto;

[0024]FIG. 8A is an enlarged, schematic top plan view of an oval convexcore, the schematic bottom plan view being identical thereto;

[0025]FIG. 8B is an enlarged, schematic elevational front view of theoval convex core of FIG. 8A, the elevational back view being identicalthereto;

[0026]FIG. 9 is a simplified, schematic elevational front view of filmcasting apparatus in accordance with a first embodiment of the presentinvention;

[0027]FIG. 10 is a simplified, schematic top plan view of the filmcasting apparatus of FIG. 9, showing the interior chambers of the slitextruder;

[0028]FIG. 11 is a simplified, schematic elevational left side view ofthe film casting apparatus of FIG. 9, looking in the direction of arrowA;

[0029]FIG. 12 is an elevational left side view of one of the partitionsthat is positioned within the slit extruder;

[0030]FIG. 13 is a perspective view of the interior roller, partitionsand slidable gate of the slit extruder of FIGS. 9-11;

[0031]FIG. 14 is a simplified, schematic elevational front view of theenrobing apparatus, including the film-casting apparatus of FIGS. 9-13,in accordance with the first embodiment of the present invention;

[0032]FIG. 15 is a top plan view of a portion of two overlapped stripedfilms with cores placed therebetween, showing the proper orientation ofthe cores in relation to the stripes on the films;

[0033]FIG. 16 is a simplified perspective view of the rotating die andstriped films, as well as enrobed cores produced thereby, in accordancewith the first embodiment of the present invention;

[0034]FIG. 17 is a simplified, schematic elevational side view of analternative film casting apparatus in accordance with a secondembodiment of the present invention;

[0035]FIG. 18 is a simplified, schematic top plan view of thealternative film casting apparatus of FIG. 17, showing the interiorchambers of the reciprocating slit extruder;

[0036]FIG. 19 a simplified, schematic elevational front view of thealternative film casting apparatus of FIG. 18, as viewed from theposition of line G-G and looking in the direction of the arrows;

[0037]FIG. 20 is a simplified perspective view of the rotating die andstriped films, as well as enrobed cores produced thereby, in accordancewith the second embodiment of the present invention;

[0038]FIG. 21 is a top plan view of a portion of two overlapped stripedfilms with cores placed therebetween, showing the proper orientation ofthe cores in relation to the stripes on the films;

[0039]FIG. 22 is a simplified, schematic elevational side view of a coredispensing means that is part of an alternative core enrobing apparatusin accordance with a third embodiment of the present invention;

[0040]FIG. 23 is a schematic perspective view of the core positioningslat shown in FIG. 22;

[0041] FIGS. 24A-24C are simplified, schematic elevational front viewsof the core positioning slat, core plunger, film and cores, as viewedfrom the position of line Q-Q in FIG. 22 and looking in the direction ofthe arrows, showing the operation of the core plunger to position coresonto the film;

[0042]FIG. 25A is a simplified, schematic elevational side view of thecore positioning slat, core plunger, film, and cores, shown in FIG. 24A;

[0043]FIG. 25B is a simplified, schematic elevational side view of thecore positioning slat, core plunger, film, and cores, shown in FIG. 24B;

[0044]FIG. 25C is a simplified, schematic elevational side view of thecore positioning slat, core plunger, film, and cores, shown in FIG. 24C;

[0045]FIG. 26 is a simplified, schematic perspective view of theconveyor system and the rotary die of the third embodiment of thepresent invention, as well as the enrobed core products producedthereby;

[0046]FIG. 27 is a simplified, schematic elevational view of a singleroller of the conveyor system, the film and a core positioned thereon,as seen from the position of line T-T in FIG. 26 and looking on thedirection of the arrows, showing the horizontal orientation of theroller;

[0047]FIG. 28 is a simplified, schematic elevational view of a firstpair of rollers of the conveyor system, the film and a core positionedthereon, as seen from the position of line V-V in FIG. 26 and looking onthe direction of the arrows, showing the slightly angled orientation ofthe rollers;

[0048]FIG. 29 is a simplified, schematic elevational view of a secondpair of rollers of the conveyor system, the film and a core positionedthereon, as seen from the position of line X-X in FIG. 26 and looking onthe direction of the arrows, showing the substantially angledorientation of the rollers;

[0049]FIG. 30 is a simplified, schematic elevational view of a thirdpair of rollers of the conveyor system, the film and a core positionedthereon, as seen from the position of line Z-Z in FIG. 26 and looking onthe direction of the arrows, showing the different configuration ofthese rollers and their vertical orientation;

[0050]FIG. 31 is a schematic elevational side view of the apparatus ofthe fourth embodiment;

[0051]FIG. 32 is a schematic perspective view of a tranversely-stripedfilm suitable for use with a porous platen having a plurality ofrecesses arranged in rows;

[0052]FIG. 33 is a schematic perspective view of a porous platen havinga plurality of recesses arranged in rows and suitable for use with thetransversely-striped film of FIG. 32;

[0053]FIG. 34 is a schematic perspective view of alongitudinally-striped film suitable for use with a porous platen havinga plurality of recesses arranged in rows;

[0054]FIG. 35 is a schematic perspective view of a porous platen havinga plurality of recesses arranged in rows and suitable for use with thelongitudinally-striped film of FIG. 34;

[0055]FIG. 36 is a partial, schematic, cross-sectional elevational sideview of a first station of the apparatus of the fourth embodiment, withthe near cross-sectional half cut away therefrom, showing how the filmis heated and vacuum formed about one half of the core;

[0056]FIG. 37 is a partial, schematic, cross-sectional elevational sideview of a second station of the apparatus of the fourth embodiment, withthe near cross-sectional half cut away therefrom, showing how the filmis cooled and molded about one half of the core;

[0057]FIG. 38 is a partial, schematic, cross-sectional elevational sideview of a third station of the apparatus of the fourth embodiment, withthe near cross-sectional half cut away therefrom, showing how the filmis cut away from the perimeter of the partially enrobed core;

[0058]FIG. 39 is a partial, schematic, cross-sectional elevational sideview of a fourth station of the apparatus of the fourth embodiment, withthe near cross-sectional half cut away therefrom, showing how thepartially enrobed core thereon is positioned beneath an inverted porousplaten for transfer thereto;

[0059]FIG. 40 is a partial, schematic, cross-sectional elevational sideview of the fourth station of FIG. 39, showing how the inverted porousplaten is lowered onto the partially enrobed core and how the twoplatens and partially enrobed core are subsequently rotated together;

[0060]FIG. 41 is a partial, schematic, cross-sectional elevational sideview of a fifth station of the apparatus of the fourth embodiment, withthe near cross-sectional half cut away therefrom, showing how a secondfilm is heated and vacuum formed about the uncovered portion of thecore;

[0061]FIG. 42 is a partial, schematic, cross-sectional elevational sideview of a sixth station of the apparatus of the fourth embodiment, withthe near cross-sectional half cut away therefrom, showing how the secondfilm is cooled and molded about the core;

[0062]FIG. 43 is a partial, schematic, cross-sectional elevational sideview of a seventh station of the apparatus of the fourth embodiment,with the near cross-sectional half cut away therefrom, showing how thesecond film is cut away from the perimeter of the fully enrobed core;and

DETAILED DESCRIPTION OF THE INVENTION

[0063] As used hereinafter, “core” shall mean a solid dosage form of anysize or shape. Suitable cores include compressed or molded tablets, hardand soft capsules, confectionery based forms such as for examplelozenges, nougats, or fondants, and the like. Cores are available invarious shapes and configurations. For example, FIGS. 1A, 1B and 2 showan oblong convex core 10 which has an oblong shape and two rounded ends12, 14, as viewed from the top, bottom or sides (see FIGS. 1A and 1B).The oblong convex core 10 may also have two oppositely positioned convexsurfaces 15, 15′ and a raised portion therebetween, referred to as aland 20 (shown most clearly in FIGS. 1B and 2).

[0064] It is noted that the length of the oblong core 10 is an imaginaryline (not shown per se, but which is commensurate with a portion of thedotted line 16 that is within the core 10 shown in FIG. 1B) whichextends the distance between the ends 12, 14 of the oblong core 10. Theheight of the oblong core 10 is another imaginary line (not shown perse, but which is commensurate with a portion of the dotted line 18 thatis within the core 10 shown in FIG. 1B) which extends the distancebetween the two opposite convex surfaces 15, 15′ of the core 10, midwayof the length. The width of the oblong core is a third imaginary line(not shown per se, but which is commensurate with a portion of thedotted line 16 that is within the core 10 shown in FIG. 2) which extendsthe distance between opposite sides of the core 10, perpendicular to andmidway of the core's length and height (and which may intersect the land20 of the core 10, if present).

[0065] To facilitate discussion hereinafter of the position of the filmsand color transitions that are applied to the enrobed core products,certain reference planes will now be defined in relation to the core 10and its length, height and width. It is noted that while a number ofdifferent references planes may be defined in relation to the oblongcore 10, the methods, apparatus and products of the present inventionwill be discussed primarily in terms of certain orthogonal planes ofsymmetry, as follows.

[0066] With reference to FIGS. 1B and 2, as used hereinafter, the“transverse”, or “major”, plane of symmetry 16 of the core 10 is thereference plane which includes the length and width of the core 10 andwhich is perpendicular to and substantially bisects the height of thecore 10. The land 20 of the core 10, if present, may be aligned with thetransverse plane of symmetry 16 (see FIGS. 1B and 2) such that the land20 is substantially bisected along its entire length. As shown in FIG.1B, it is noted that a portion of the core 10 which lies on one side ofthe transverse plane of symmetry 16 is substantially a mirror image ofthe remaining portion of the core 10 which lies on the opposite side ofthe transverse plane of symmetry 16.

[0067] With reference to FIGS. 1A and 1B, as used hereinafter, the“conjugate”, or “minor” plane of symmetry 18 of the oblong core 10 isthe reference plane which includes the width and height of the core 10and which is perpendicular to and substantially bisects the length ofthe core 10. As with the transverse plane of symmetry 16, a portion ofthe core 10 which lies on one side of the conjugate plane of symmetry 18is substantially a mirror image of the other side of the core 10 whichlies on the opposite side of the conjugate plane of symmetry 18.

[0068] With reference now to FIGS. 1A and 2, a third plane of symmetry17 includes the length and height of the core 10 and is perpendicular toand substantially bisects the width of the core 10. As with thetransverse and conjugate planes of symmetry 16, 18, respectively, aportion of the core 10 which lies on one side of the third plane ofsymmetry 17 is substantially a mirror image of the other side of thecore 10 which lies on the opposite side of the third plane of symmetry17.

[0069] It is noted that additional reference planes can be defined,including many which are not planes of symmetry. For example, areference plane 19 (see FIG. 1B) may be defined that is parallel to thelength and width of the core 10, but does not include the length orwidth and does not divide the core into mirror image portions. Inaddition, another reference plane 21 (see FIG. 2) could be defined suchthat it is parallel to the length of the core 10, perpendicular to boththe width and height of the core 10, but does not include any of thelength, width or height of the core and does not divide the core intomirror image portions. It will be understood by a person having ordinaryskill in the art that many additional possibilities exist for definingreference planes in relation to the core 10. However, the remainingdescription of the method, apparatus and products of the presentinvention will be discussed using, primarily, the transverse andconjugate planes of symmetry 16, 18, respectively.

[0070] With reference now to FIGS. 3-8A, examples are provided of coreshaving shapes and configurations different from the oblong convex core10 shown in FIGS. 1A, 1B and 2. More particularly, as shown in FIGS. 3and 4, an oblong convex core 10 a may, alternatively, have a centralcylindrical subsection 22 between the two rounded ends 12 a, 14 a (i.e.,instead of a land 20). The core 10 a shown in FIGS. 3 and 4 includes atransverse plane of symmetry 16 a and a conjugate plane of symmetry 18a, the orientation of which are defined in the same manner as providedabove in connection with the oblong core 10 of FIGS. 1A, 1B and 2. Ascan be seen from FIGS. 3 and 4, the rounded ends 12,′ 14′ of the caplet10′ are of slightly smaller diameter than the cylindrical subsection 20.

[0071]FIGS. 5, 6, 7A and 7B provide examples of “round” cores, which arecores having a generally round or circular configuration when viewedfrom above (see the top views shown in FIGS. 5 and 7A). In addition,while round cores have a length, a width and a height, the length andwidth of each round core are dimensionally interchangeable due to thegenerally circular configuration of each round core.

[0072] With reference in particular to FIGS. 5 and 6, a “round convex”core 24 may have two oppositely positioned convex surfaces 25, 25′ whichare seen most clearly from a front, back or side elevational view, suchas provided in FIG. 6. The round convex core 24 includes a transverseplane of symmetry 26 and a conjugate plane of symmetry 28, theorientation of which are defined in the same manner as provided above inconnection with the oblong core 10 of FIGS. 1A, 1B and 2. As also seenmost clearly in FIG. 6, the round convex core 24 may also have a raisedportion, or land 20′, similar to the land 20 of the oblong convex core10 of FIGS. 1A, 1B and 2.

[0073] With reference now to FIGS. 7A and 7B, a “round flat” core 24 amay have two oppositely positioned flat surfaces 25 a, 25 a′ (i.e.,rather than convex surfaces). The round flat core 24 a may also have abeveled edge 27 a positioned 27 a proximate to one flat surface 25 a(see FIGS. 7A and 7B) and another beveled edge 27 a′ positionedproximate to the other flat surface 25 a′ (see FIG. 7B) of the roundflat core 24 a. The round flat core 24 a includes a transverse plane ofsymmetry 26 a and a conjugate plane of symmetry 28 a, the orientation ofwhich are defined in the same manner as provided above in connectionwith the oblong core 10 of FIGS. 1A, 1B and 2.

[0074]FIGS. 8A and 8B provide one example of a type of “oval” core 24 b.Generally, “oval” cores are cores having have a generally ovalconfiguration when viewed from above (see, for example, the top viewshown in FIG. 8A). An “oval convex” core 24 b, shown in FIGS. 8A and 8B,may have two oppositely positioned convex surfaces 25 b, 25 b′ which areseen most clearly from a front, back or side elevational view, such asprovided in FIG. 8B. The oval convex core 24 b includes a transverseplane of symmetry 26 b and a conjugate plane of symmetry 28 b, theorientation of which are defined in the same manner as provided above inconnection with the oblong core 10 of FIGS. 1A, 1B and 2. As seen mostclearly in FIG. 8B, the oval convex core 24 b may also have a raisedportion, or land 20 b′, similar to the land 20 of the oblong convex core10 of FIGS. 1A, 1B and 2.

[0075] It is noted that, while the present invention has applicabilityto core dosage forms of various shapes, including but not limited to theshapes shown in FIGS. 1A-8B, the remaining drawing figures and thedetailed description provided hereinafter show and discuss the apparatusand methods of the present invention as applied to the oblong convexcaplet 10 of the first configuration exemplified in FIGS. 1A, 1B and 2.It is understood, however, that the present invention may also beapplied to differently shaped cores, including, but not limited to, thecores of other configurations, including oblong, round and oval cores,shown in FIGS. 3-8B.

[0076] The product of the present invention, which is produced by themethods and apparatus of the present invention described hereinafter, isan enrobed substrate (also referred to herein as a “core”). Such enrobedproducts are often referred to as “geltabs” or “gelcaps”. The terms“geltabs” and “gelcaps” shall mean a substrate having at least one,non-core layer, or film, made of a film forming or gel forming substanceor to substances. The substrate, or core may be a compressed tablet, orother non-liquid (e.g., solid or semi-solid) dosage form.

[0077] More particularly, as will be described in further detailhereinafter, the enrobed core of the present invention is enrobed by atleast one film having at least two visually distinct portions (i.e., atleast two portions having different visual appearances) and at least onevisual transition line between the visually distinct portions of thefilm. It is noted that, hereinafter, the apparatus and method of thepresent invention are discussed as producing enrobed cores that aresubstantially enrobed by the film or films and the term “substantially”shall be understood to mean that at least about 95% of the surface areaof the core is covered by the film or films. Furthermore, it will beunderstood by those having ordinary skill in the art that the apparatusand method of the present invention may be adapted to produce enrobedcore products that are at least partially covered by the film or films.The term “at least partially covered” shall be understood to mean thatat least about 25% to about 100% of the surface area of the core iscovered by the film or films.

[0078] It is further noted that the visually distinct portions of thepatterned film or films may be of different colors, hues, glosses,reflective qualities, brightness, depth, shades, chroma, opacity, etc.Patterned films may also be embossed or etched with surface reliefpatterns for textural and visual effects, as in the case of aholographic image or pattern. For example, the patterned film could haveat least two portions having different visual appearances as follows: ared portion and a yellow portion (such as red and yellow stripes, or ared background having yellow spots thereon), or a flat finish portionand a glossy portion, or an opaque portion and a translucent portion.While the apparatus and methods of the present invention will bediscussed hereinafter as employing films that have differently coloredstripes (i.e., red and yellow stripes) with a color transition linetherebetween, it will be understood that the patterned films may haveany of the foregoing types of visually distinct portions, orcombinations thereof, including visual distinctions not specificallymentioned herein.

[0079] It is further noted that the films of the present invention maybe made of any elastic, plastic material (i.e., stock film formingmaterial) that is preferably pharmaceutically acceptable and which is,or can be made, semi-liquid and flowable to facilitate the formation ofa patterned, seamless and continuous film that can be made formable andmalleable and which has smooth and controllable transition lines betweenthe visually distinct portions thereof. More particularly, the films ofthe present invention may be formed of various materials, including, butnot limited to, compositions comprising, consisting of, and/orconsisting essentially of a film former; optionally a thickener;optionally an extender, optionally a plasticizer, and optionally variousadjuvants and excipients.

[0080] Any film former known in the art is suitable for use in filmcomposition of the present invention. Examples of suitable film formingmaterials include, but are not limited to, cellulosics such asmethylcellulose, hydroxypropylcellulose (HPC),hydroxyethylmethylcellulose (HEMC), hydroxypropylmethylcellulose (HPMC),hydroxybutylmethylcellulose (HBMC), hydroxyethylethylcellulose (HEEC),and hydroxyethylhydroxypropylmethyl cellulose (HEMPMC); modifiedstarches such as cross-linked starches, chemically modified starchesincluding hydroxypropyl starch, hydroxyethyl starch, methylethyl starch,carboxymethyl starch; and physically modified starches includingpre-gelatinized starches; proteins such as gelatin, whey protein, eggalbumin, casein and casein isolates, soy protein and soy proteinisolates; and other film-forming polymers such as polyvinylalcohol(PVA), methacrylic acid and methacrylate ester copolymers, polyvinylalcohol and polyethylene glycol copolymers, and derivatives and mixturesthereof.

[0081] One suitable hydroxypropylmethylcellulose compound is “HPMC2910”, which is a cellulose ether having a degree of substitution ofabout 1.9 and a hydroxypropyl molar substitution of 0.23, andcontaining, based upon the total weight of the compound, from about 29%to about 30% methoxyl and from about 7% to about 12% hydroxylpropylgroups. HPMC 2910 is commercially available from the Dow ChemicalCompany under the tradename, “METHOCEL E.” “METHOCEL E5,” which is onegrade of HPMC-2910 suitable for use in the present invention, has aviscosity of about 4 to 6 cps (4 to 6 millipascal-seconds) at 20 degreesCelsius in a 2% aqueous solution as determined by a Ubbelohdeviscometer. Similarly, “METHOCEL E6,” which is another grade ofHPMC-2910 suitable for use in the present invention, has a viscosity ofabout 5 to 7 cps (i.e., 5 to 7 millipascal-seconds) at 20 degreesCelsius in a 2% aqueous solution as determined by a Ubbelohdeviscometer. “METHOCEL E15,” which is another grade of HPMC-2910 suitablefor use in the present invention, has a viscosity of about 15000 cps (15millipascal-seconds) at 20 degrees Celsius in a 2% aqueous solution asdetermined by a Ubbelohde viscometer. As used herein, “degree ofsubstitution” shall mean the average number of substituent groupsattached to a anhydroglucose ring, and “hydroxypropyl molarsubstitution” shall mean the number of moles of hydroxypropyl per moleanhydroglucose.

[0082] One suitable polyvinyl alcohol and polyethylene glycol copolymeris commercially available from BASF Corporation under the tradename“KOLLICOAT IR”.

[0083] As used herein, “modified starches” include starches that havebeen modified by crosslinking, chemically modified for improvedstability or optimized performance, or physically modified for improvedsolubility properties or optimized performance. Chemically modifiedstarches have typically been treated with chemicals so that somehydroxyl groups have been replaced by either ester or ether groups. Verylow levels of chemical modification can significantly change theTheological, physical, and chemical properties of starch. Crosslinking,in which two hydroxyl groups on neighboring starch molecules are linkedchemically is also a form of chemical modification. As used herein,“pre-gelatinized starches” or “instantized starches” refers tophysically modified starches that have been pre-wetted, then dried toenhance their cold-water solubility. Acid-hydrolyzed starch is a termused for a starch suspension treated with dilute acid at a temperaturebelow the gelatinization point. The granular form of the starch ismaintained and the reaction is ended by neutralization, filtration anddrying once the desired degree of conversion is reached. This results ina reduction in the average molecular size of the starch polymers.Acid-hydrolyzed starches tend to have a lower hot viscosity than nativestarch and a strong tendency to gel when cooled. Suitable modifiedstarches are commercially available from several suppliers such as, forexample, A. E. Staley Manufacturing Company, and National Starch &Chemical Company.

[0084] One suitable modified starch includes the pre-gelatinized waxymaize derivative starches that are commercially available from NationalStarch & Chemical Company under the tradenames, “PURITY GUM” and“FILMSET”, and derivatives, copolymers, and mixtures thereof. Such waxymaize starches typically contain, based upon the total weight of thestarch, from about 0% to about 18% of amylose and from about 100% toabout 88% of amylopectin.

[0085] Another suitable modified starch includes the hydroxypropylatedstarches. These are starches in which some of the hydroxyl groups havebeen etherified with hydroxypropyl groups, usually by treatment withpropylene oxide. These starches are characterized by having excellentrefrigeration and freeze/thaw stability. Hydroxypropyl food starches aregenerally crosslinked in addition to the etherification. Hydroxypropyldistarch phosphate is a starch used widely in the food industry in whichboth monofunctional hydroxypropyl groups have been added in combinationwith phosphate crosslinking. One example of a suitable hydroxypropylstarch is commercially available from Grain Processing Company under thetradename, “PURE-COTE B790”.

[0086] Suitable tapioca dextrins include those available from NationalStarch & Chemical Company under the tradenames “CRYSTAL GUM” or“K-4484”, and derivatives thereof such as modified food starch derivedfrom tapioca, which is available from National Starch and ChemicalCompany under the tradename “PURITY GUM 40”, and copolymers and mixturesthereof.

[0087] Any thickener known in the art is suitable for use in the filmcomposition of the present invention. Examples of such thickenersinclude but are not limited to hydrocolloids such as alginates, agar,guar gum, locust bean gum, kappa carrageenan, iota carrageenan, tara,gum arabic, tragacanth, pectin, xanthan gum, gellan gum, maltodextrin,galactomannan, pusstulan, laminarin, scleroglucan, gum arabic, inulin,pectin, whelan, rhamsan, zooglan, methylan, chitin, cyclodextrin,chitosan, clays, acid hydrolyzed starches and derivatives and mixturesthereof. Additional suitable thickeners include sucrose, dextrose,fructose, and the like, and derivatives and combinations thereof.

[0088] Suitable xanthan gums include those available from C. P. KelcoCompany under the tradename, “KELTROL 1000,” “XANTROL 180,” or “K9B310.”

[0089] Suitable clays include smectites such as bentonite, kaolin, andlaponite; magnesium trisilicate, magnesium aluminum silicate, and thelike, and derivatives and mixtures thereof. The smectites are a group ofminerals that swell as they absorb water or organic molecules within thestructural layers; they also have considerable cationic exchangeproperties.

[0090] Suitable acid hydrolyzed starches include that commerciallyavailable from Grain Processing Corporation under the tradename,“PURE-SET B950”, and hydroxypropyl distarch phosphates such as thatcommercially available from Grain Processing Corporation under thetradename, “PURE-GEL B990”.

[0091] Suitable extenders include malotdextrin and polydextrose andmixtures and derivatives thereof.

[0092] Any plasticizer known in the pharmaceutical art is suitable foruse in the present invention, and may include, but not be limited topolyethylene glycol; glycerin; sugar alcohols; triethyl citrate; tribuylcitrate; dibutyl sebecate; vegetable oils such as castor oil;surfactants such as polysorbates, sodium lauryl sulfates, anddioctyl-sodium sulfosuccinates; propylene glycol; mono acetate ofglycerol; diacetate of glycerol; triacetate of glycerol; natural gumsand mixtures thereof. Suitable sugar-alcohols include sorbitol,mannitol, xylitol, maltitol, erythritol, lactitol, and mixtures thereof.In solutions containing a cellulose ether film former, an optionalplasticizer may be present in an amount, based upon the total weight ofthe solution, from about 0% to about 40%.

[0093] Other suitable film materials include the gelatin-based materialdisclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983, as well as othermaterials discussed therein that include, but are not limited to,polymers, such as polyvinyl chloride and polyvinyl pyrrolidone.

[0094] In one embodiment, the film composition contains, based upon thetotal dry solids weight of the composition, from about 95% to less thanabout 100%, e.g. from about 95% to about 99.5%, of a film former such asa cellulose ether, e.g., hydroxypropylmethylcellulose; and optionallyfrom about 0.5% to about 5% of a thickener such as a hydrocolloid, e.g.,xanthan gum; and optionally, from about 0.1% to about 1.0%, e.g. fromabout 0.25% to about 0.5% of a plasticizer such as vegetable oils, e.g.castor oil.

[0095] In an embodiment wherein the film forming agent is athermoplastic starch, the film composition may include from about 60% toabout 90% thermoplastic starch, about 0.5% to about 10% plasticizers,about 0% to about 40% hydrophilic extenders such as gelatin and about 0%to about 5% release aids such as fats or waxes. The formulation of suchembodiments is described in further detail in U.S. Pat. Nos. 5,427,614and 4,673,438. The portions of U.S. Pat. Nos. 5,427,614 and 4,673,438which disclose the formulations and the methods of producing suchformulations are hereby incorporated herein by reference.

[0096] In another embodiment, wherein the film forming agent is acellulose either, such as hydroxypropylmethylcellulose (HPMC), the filmcomposition may include about 70% to about 90%hydroxypropylmethylcellulose (HPMC), about 5% to about 20% plasticizers,such as glycerine or polyethylene glycol, about 0.5% to about 2.5% waterand about 1% to about 20% hydrophilic extenders such as gelatin. Theformulation of such embodiments is described in further detail in U.S.Pat. Nos. 4,655,840 and 4,790,881. The portions of U.S. Pat. Nos.4,655,840 and 4,790,881 which disclose the formulations and the methodsof producing such formulations are hereby incorporated herein byreference.

[0097] In a further embodiment, wherein the film forming agent is achemically modified starch, the thickener may be selected from the groupconsisting of kappa or iota carrageenan, maltodextrin, gellan gum, agar,thin boiling starch, hydroxypropyl distarch phosphate and derivativesand mixtures thereof.

[0098] In another embodiment, wherein the film forming agent is achemically modified starch, the plasticizer may be selected from thegroup consisting of glycerin, propylene glycol, polyethylene glycol,sugar alcohols and derivatives and mixtures thereof.

[0099] Optionally, the composition may further comprise otheringredients such as, based upon the total weight of the formulation,from about 0% to about 2% preservatives such as methylparaben andpropylparaben, from about 0% to about 14% opacifying agents such astitanium dioxide, and/or from about 0% to about 14% colorants. SeeRemington's Practice of Pharmacy, Martin & Cook, 17^(th) ed., pp.1625-30, which is herein incorporated by reference.

[0100] Any coloring agent suitable for use in pharmaceuticalapplications may be used in the present invention and may include, butnot be limited to azo dyes, quinopthalone dyes, triphenylmethane dyes,xanthene dyes, indigoid dyes, iron oxides, iron hydroxides, titaniumdioxide, natural dyes, and mixtures thereof. More specifically, suitablecolorants include, but are not limited to patent blue V, acid brilliantgreen BS, red 2G, azorubine, ponceau 4R, amaranth, D&C red 33, D+C red22, D+C red 26, D+C red 28, D+C yellow 10, FD+C yellow 5, FD+C yellow 6,FD+C red 3, FD+C red 40, FD+C blue 1, FD+C blue 2, FD+C green 3,brilliant black BN, carbon black, iron oxide black, iron oxide red, ironoxide yellow, titanium dioxide, riboflavin, carotenes, anthocyanins,turmeric, cochineal extract, clorophyllin, canthazanthin, caramel,betanin, and mixtures thereof.

[0101] In one embodiment, the dosage form is comprised of a) a core; b)an optional first coating layer comprised of a subcoating thatsubstantially covers the core; and c) a second coating layer on thesurface of the first coating layer, the second coating layer comprisedof the coating composition of the present invention. As used herein,“substantially covers” shall mean at least about 95% of the surface areaof the core is covered by the subcoating. In a preferred embodiment thecore contains a pharmaceutically active ingredient.

[0102] In an alternate embodiment, a first active ingredient may becontained in the first coating layer, and the core may contain a secondactive ingredient and/or an additional amount of the first activeingredient. In yet another embodiment, the active ingredient may becontained in the first coating layer, and the core may be substantiallyfree, i.e., less than about 1%, e.g. less than about 0.1%, of activeingredient.

[0103] The use of subcoatings is well known in the art and disclosed in,for example, U.S. Pat. No. 3,185,626, which is incorporated by referenceherein. Any composition suitable for film-coating a tablet may be usedas a subcoating according to the present invention. Examples of suitablesubcoatings are disclosed in U.S. Pat. Nos. 4,683,256, 4,543,370,4,643,894, 4,828,841, 4,725,441, 4,802,924, 5,630,871, and 6,274,162,which are all incorporated by reference herein. Additional suitablesubcoatings include one or more of the following ingredients: celluloseethers such as hydroxypropylmethylcellulose, hydroxypropylcellulose, andhydroxyethylcellulose; polycarbohydrates such as xanthan gum, starch,and maltodextrin; plasticizers including for example, glycerin,polyethylene glycol, propylene glycol, dibutyl sebecate, triethylcitrate, vegetable oils such as castor oil, surfactants such aspolysorbate-80, sodium lauryl sulfate and dioctyl-sodium sulfosuccinate;polycarbohydrates, pigments, and opacifiers.

[0104] The first embodiment of the present invention is directed to anovel rotary die apparatus and a method of enrobing cores using same.Initially, it is noted that, while various types of stock film formingmaterials are suitable for use in the embodiments described herein,gelatin-based materials are preferred.

[0105] U.S. Pat. Nos. 5,146,730 and 5,459,983 provide a complete anddetailed description of the rotary die apparatus and method of enrobingcores to produce gelcaps suitable for use in the apparatus and method ofthe first embodiment. Accordingly, only those portions of the rotary dieenrobing apparatus and process that are new and/or modified inaccordance with the present invention will be described in full detailhereinafter.

[0106] Referring now to FIGS. 9-11, there are shown front (see FIG. 9),top (see FIG. 10) and side (see FIG. 11) representations of a filmcasting apparatus 30 used to produce a patterned film, more particularlya striped film 32, for enrobing cores 10 in accordance with the firstembodiment of the present invention. More particularly, the film castingapparatus 30 includes film receiving means, such as a conventionalcasting drum 34 (see FIGS. 9 and 11), for receiving the film 32 castthereon, as described in further detail hereinafter. The casting drum 34rotates at a controllable rate in the direction indicated by the arrow Bin FIG. 11. The casting drum 34 has an exterior surface 36, which may bepolished and which may be cooled by conventional cooling means, such ascirculating cooled water within the drum (not shown), for reasonsdiscussed hereinafter.

[0107] With reference now, in particular, to FIGS. 10 and 11, the filmcasting apparatus 30 further includes film depositing means, such as amulti-chamber slit extruder 38, for depositing the film 32 (see FIGS.9-11) onto the casting drum 34. The film 32 is made of any stock filmforming materials 40, 42 that are suitable for use in conjunction withthe multi-chamber slit extruder 38. It is noted that FIG. 10 shows thefilm casting apparatus 30 as viewed from the top; and, therefore, itshows the interior 44 of the multi-chamber slit extruder 38. FIG. 11shows the film casting apparatus 30 from the left side (i.e., looking inthe direction of arrow A in FIG. 9), with the slit extruder 38 inpartial cross section, such that the interior 44 thereof is partiallyvisible. As shown in these figures, the slit extruder 38 has, generally,a floor panel 46 and four exterior walls 48, 50, 52, 54 (see FIG. 10),which define the interior 44 of the slit extruder 38. The slit extruder38 also includes flow control means, such as a slidable gate 56 (seeFIG. 11), for a purpose to be described hereinafter. Three partitions58, 60, 62 divide the interior 44 of the slit extruder 38 into fourchambers 64, 66, 68, 70. In this regard, it is noted that the slitextruder 38 may include more or fewer partitions than are shown in thepresent embodiment resulting in more or fewer chambers, respectively,than are shown in the present embodiment. The film casting apparatus 30also includes supply means, such as feeder pipes 72, 74 (shown inpartial cross section in FIGS. 9-11 to reveal the stock film formingmaterials 40, 42 flowing therethrough) for supplying stock film formingmaterials 40, 42 to the chambers 64, 66, 68, 70 in a manner to bedescribed hereinafter.

[0108] As can be seen best in FIG. 11, one of the exterior walls 48 ofthe slit extruder 38 may have an inner surface 76 that is sloped towardthe floor panel 46 and terminates proximate thereto, thus forming anopen slit 78 between the bottom-most portion of the wall 48 and thefloor panel 46. The open slit 78 communicates with each of the chambers64, 66, 68, 70 of the slit extruder 38 to allow passage therethrough ofthe stock film forming materials 40, 42. The slit extruder 38 is heatedby conventional heating means, such as electric coils, or coils with hotwater circulating therein (not shown), for the purpose of heating thestock film forming materials 40, 42 to (or maintaining the stock filmforming materials 40, 42 at) a flowable liquid state, such that thestock film forming materials 40, 42 will flow through the slit 78 andout of the chambers 64, 66, 68, 70 in a manner to be describedhereinafter. The width of the slit 78, and, hence, the thickness of theresulting film 32, is adjusted by moving the slidable gate 56 in thedirections indicated by arrow C in FIG. 11.

[0109] The slit extruder 38 may also include a top cover 80 (see FIGS. 9and 11) to facilitate pressurizing the interior 44 of the slit extruder38 by conventional pressurizing means (not shown), which will encouragethe stock film forming materials 40, 42 to flow out of the chambers 64,66, 68, 70 in a manner to be described hereinafter. As a furtheroptional feature, the slit extruder 38 may include an interior roller 82(see FIG. 11), which is adapted to rotate in the direction indicated bythe arrow D so as to encourage the stock film forming materials 40, 42to flow out of the chambers 64, 66, 68, 70 in a manner to be describedhereinafter.

[0110] As shown in FIGS. 9-11, when the chambers 64, 66, 68, 70 of theslit extruder 38 contain differently colored stock film formingmaterials 40, 42 in alternating chambers 64, 66, 68, 70 (e.g., “red”stock material 40 in the chambers 64, 68 and “yellow” stock material 42in the chambers 66, 70), the resulting film 32 will have differentlycolored stripes (i.e., red stripes 84, 88 and yellow stripes 86, 90). Inaddition, where the slit extruder 38 includes more or fewer chambersthan are shown in FIGS. 9-11, the resulting striped film 32 will havemore or fewer stripes, respectively, than the film 32 shown in thepresent embodiment.

[0111] It is noted that, of course, the stock film forming materials 40,42 need not be of different colors, but rather, they can be visuallydistinct from one another by having, for example, different colors,hues, glosses, reflective qualities, brightness, depth, shades, chroma,opacity, etc. Red and yellow stock film forming materials 40, 42,respectively, are discussed herein merely by way of example and, itshould be understood that stock film forming materials that are visuallydistinct from one another in other ways, as mentioned above, are alsosuitable for use with the apparatus and method of the present invention.Furthermore, stock film forming materials 40, 42 of more than twodifferent colors (for example, four stock materials of four differentcolors), or other visual distinctions (such as, for example, a firstflat stock material, a second glossy stock material and a third stockmaterial having reflective qualities), may also be used. It is furthernoted that the stock film forming materials 40, 42 may be of differentchemical compositions (i.e., they need not both be made of polymer orstarch-based materials, or even of the same polymer or starch-basedformulation) and still be suitable for use with the apparatus andmethods of the present invention as long as the stock film-formingmaterials are sufficiently compatible with one another such that theywill form a continuous patterned film by the methods describedhereinafter.

[0112] With reference now to FIGS. 12 and 13, to ensure that the colortransitions 92 a, 92 b, 92 c between stripes 84, 86, 88, 90 of differentcolors (or visual distinction) in the film 32 are straight andconsistent (see, e.g., FIG. 9), the slit extruder 38 includes a stripecontrol means, such as a tapered blade edge 94, 96, 98 on each partition58, 60, 62, respectively, to control the flow of the stock film formingmaterials 40, 42 as they exit the chambers 64, 66, 68, 70. FIG. 12 showsa single isolated partition 58, removed from the slit extruder 38 andhaving a tapered blade edge 94, as well as a hole 100 that is sized andshaped to rotatably receive the interior roller 82 therethrough. Asshown in FIG. 13, when the partitions 58, 62, 62 and the interior roller82 are properly installed within the slit extruder 38, the tapered edge94, 96, 98 of each partition 58, 60, 62, respectively, rests upon thefloor panel 46 and extends across the slit 78.

[0113] The operation of the film casting apparatus 38, by which stripedfilm 32 is produced, will now be described in detail using FIGS. 9-13 asreferences. Initially, one feeder pipe 72 supplies the stock filmforming material 40 of one color (or visual distinction), such as red,to two alternate chambers 64, 68 of the slit extruder 38, while theother feeder pipe 74 supplies stock film forming material 42 of anothercolor (or visual distinction), such as yellow, to the remaining twochambers 66, 70. The stock film forming materials 40, 42 may be providedto the extruder 38 in the form of liquid, a solid, or a semi-solid, andmay be at any desired temperature. A conventional heating means (notshown) of the slit extruder 38 may be activated, thereby heating thestock film forming materials 40, 42 within the chambers 64, 66, 68, 70to a predetermined temperature (or maintaining the stock film formingmaterials 40, 42 at such a temperature), at which the stock film formingmaterials 40, 42 become liquid and flowable or may be maintained in aliquid and flowable state. Depending upon the type and composition ofthe stock film forming materials 40, 42, it may be exposed to atemperature between about 40 degrees Celsius and about 250 degreesCelsius. For example, where the stock film forming materials 40, 42 aregelatin based or hydroxypropyl methylcellulose based, then theappropriate temperature range for heating within the slit extruder 38would be between about 40 degrees Celsius and about 190 degrees Celsius.Alternatively, where the stock film forming materials 40, 42 are starchbased, then the appropriate temperature range for heating within theslit extruder 38 would be between about 80 degrees Celsius and about 240degrees Celsius.

[0114] According to known, conventional processes, the rotation of thecasting drum 34 is commenced and the exterior surface 36 of the castingdrum 34 is cooled by conventional cooling means (not shown) to apredetermined temperature that will, at least partially, solidify thestock film forming materials 40, 42 upon their physical contact with thesurface 36 of the drum 34 to form the striped film 32, as described infurther detail hereinafter. One skilled in the art would readilyappreciate, without undue experimentation, the proper predeterminedtemperature for the exterior surface 36 of the drum 34 will depend uponseveral factors such as, for example, the type and composition of thestock film forming materials 40, 42 and the desired thickness of theresulting film 32. For example, where the stock film forming materials40, 42 are gelatin based or hydroxypropyl methylcellulose based, and thedesired film thickness is about 0.1 millimeters to about 2.0millimeters, then the appropriate temperature range for cooling theexterior surface 36 of the casting drum 34 would be between about 2degrees Celsius and about 50 degrees Celsius. Alternatively, where thestock film forming materials 40, 42 are thermoplastic starch based, andthe desired film thickness is about 0.1 millimeters and about 2.0millimeters, then the appropriate temperature range for cooling thesurface 36 of the drum 34 would be between about 20 degrees Celsius andabout 100 degrees Celsius.

[0115] After the stock film forming materials 40, 42 are heated to, ormaintained at, the appropriate predetermined temperature and theexterior surface 36 of the casting drum 34 is cooled to the appropriatepredetermined temperature, the slidable gate 56 of the slit extruder 38is moved to a position which opens the slit 78 to the thickness that isdesired for the film 32. The stock film forming materials 40, 42 thenflow out of their respective chambers 64, 66, 68, 70, along the taperedblade edges 94, 96, 98, through the slit 78, and onto the casting drum34, in a controlled manner, in the direction of the arrow E in FIG. 9.The aforesaid apparatus and procedure result in the production of acontinuous ribbon of striped film 32, having alternating red stripes 84,88 and yellow stripes 86, 90, with straight and consistent colortransitions 92 a, 92 b, 92 c therebetween. The film 32 is continuouslyremoved from the casting drum 34 by a scraper or similar device (notshown).

[0116] With reference now to FIGS. 14-16, a summary of the enrobingapparatus 102 (see FIG. 14) in accordance with the first embodiment ofthe present invention will now be provided. Reference is also made toU.S. Pat. Nos. 5,146,730 and 5,459,983, which both provide a detaileddescription of the enrobing apparatus 102.

[0117] With reference in particular to FIG. 14, it is noted that theenrobing apparatus 102 has a central plane of symmetry 104 about whichthe various equipment that comprises the enrobing apparatus 102 arearranged. As depicted schematically in FIG. 14, it can be seen that theequipment of the enrobing apparatus 102 on one side of the central planeof symmetry 104 is basically the same type as the equipment on the otherside of the central plane of symmetry 104 and is arranged, generally, ina mirror image thereof. More particularly, a film casting apparatus 30,30′ is positioned at each of the opposite ends of the enrobing apparatus102 and each film casting apparatus 30, 30′ produces a striped film 32,32′, respectively. Each film, 32, 32′ is moved in a continuous manner,by a series of rollers 106, 108, 110, and 106′, 108′, 110′,respectively, toward a pair of coacting rotary dies 112, 112′, which arepositioned symmetrically on either side of the central plane of symmetry104. The rotary dies 112, 112′ rotate on their axes of rotation AR, AR′,respectively, in the directions of arrows F, F′, respectively, therebyforming a nip therebetween. The nip between the rotary dies 112, 112′lies in the aforesaid central plane of symmetry 104 and the stripedfilms 32, 32′ are passed therethrough.

[0118] Each film 32, 32′ includes a top or contact surface 32 a, 32 a′and a reverse surface 32 b, 32 b′, respectively (see FIG. 14). Shortlyafter the striped films 32, 32′ are cast and removed from the cooledcasting drums 34, 34′, as described earlier hereinabove, the reversesurface 32 b, 32 b′ of each film 32, 32′ may be lubricated in alubricant bath 114, 114′ to facilitate their movement over the rollers106, 108, 110, 106′, 108′, 110′. Suitable lubricants include any fats oroils, which are well-known in the art for such use. Just prior to thepassage of the films 32, 32′ into the nip between the rotary dies 112,112′, the contact surface 32 a, 32 a′ of each of the films 32, 32′ maybe heated by conventional heating means 116, 116′ to facilitate theirbonding to one another as they pass between the rotary dies 112, 112′.

[0119] The enrobing apparatus 102 also includes a core dispensing means118, which holds a supply of cores 10 and dispenses them to the nipbetween the rotary dies 112, 112′ in a timed manner. Although thisembodiment is illustrated as enrobing cores, it is within the scope ofthe present invention to alternatively enrobe any substrate with adesired film coating, including but not limited to a hard or softcapsules, gels, lozenges, nougats, fondants, etc., or otherconfectionery. The core dispensing means 118 is aligned with the centralplane of symmetry 104 and the nip formed between the rotary dies 112,112′. The core dispensing means 118 orients and dispenses each core 10such that the core 10 simultaneously contacts the contact surfaces 32 a,32 a′ of the converging striped films 32, 32′ as the core 10 enters thenip between the dies 112, 112′, with its transverse plane of symmetry 16lying in the central plane of symmetry 104 of the enrobing apparatus102, and the color transitions 92 a, 92 a′ of the films 32, 32′,respectively, lying in the conjugate plane of symmetry 18 of the core10. The films 32, 32′ are then stretched around the opposite sides ofeach core 10 symmetrically, relative to the central plane of symmetry104 of the enrobing apparatus 102.

[0120]FIG. 15 shows the proper positioning of the cores 10 in betweenthe striped films 32, 32′ as they enter the nip between the dies 112,112′ and relative to the color transitions 92 a, 92 b, 92 c, 92 a′, 92b′, 92 c′ of each film 32, 32′. In FIG. 15, the first film 32 ispartially cut away to show the cores 10 placed on the second film 32′.The cores 10 that are shown in phantom in FIG. 15 are sandwiched inbetween the films 32, 32′, thereby showing how the color transitions 92a, 92 b, 92 c of the first film 32 align with the color transitions 92a′, 92 b′, 92 c′ of the second film 32′, respectively, and how all ofthe color transitions 92 a, 92 b, 92 c, 92 a′, 92 b′, 92 c′ are alignedwith the conjugate plane of symmetry 16 (not shown on the phantom cores10) of a corresponding core 10.

[0121] Furthermore, the enrobing apparatus 102 preferably includesregistering means 120 (shown only schematically in FIG. 14) for ensuringthat the colored stripes (not shown) of the films 32, 32′ are properlyaligned with one another prior to passage between the rotary dies 112,112′. The registering means 120 also ensures that the positions of thedispensed cores 10 are appropriate relative to the color transitions 92a, 92 b, 92 c, 92 a′, 92 b′, 92 c′ of the films 32, 32′, respectively,such that the color transition between the colors on the resultinggelcap products 122 are properly matched with one another and theconjugate plane of symmetry 18 of each core 10. More particularly, theregistering means 120 (shown schematically only in FIG. 14) may includeany one of many any other conventional, known types of optical sensoryand control devices (commercially available from Contrex, Inc. of MapleGrove, Minn. and Ormec Systems Corp. of Rochester, N.Y.), as well as anyother conventional, known mechanical adjusting means for adjusting theposition of one or both of the films 32, 32′, as necessary.

[0122] With reference now to FIG. 16, an enlarged schematic perspectiveview of the drum-like rotary dies 112, 112′ is provided. As shown, therotary dies 112, 112′ are substantially identical to one another, eachhaving an exterior circumferential surface 124, 124′ with a series ofrecesses 126, 126′ thereon. The recesses 126, 126′ are arranged in rows,which extend circumferentially around each rotary die 112, 112′.Furthermore, each recess 126, 126′ has a raised rim 128, 128′ about itsperiphery for a purpose to be described hereinafter. It is noted that,as shown in FIG. 16, each recess 126, 126′ is shaped to conform to theshape of the cores 10 being enrobed. More particularly, for purposes ofthe present illustration wherein oblong cores 10 are being enrobed, eachrecess 126, 126′ has a length 130, 130′ and a width 132, 132′ and eachis arranged such that its length 130, 130′ is aligned parallel to theaxis of rotation AR, AR′ of its respective rotary die 112, 112′. Inaddition, it is contemplated that each die 112, 112′ may have adifferent number of rows of recesses 126, 126′ than are shown in thepresent embodiment, as long as there are the same number of rows on eachdie 112, 112′ so that each recess 126 on one die 112 can cooperate witha corresponding recess 126′ on the other die 112′, as described infurther detail hereinafter. In addition, the number of rows of recesses126, 126′ should correspond to the number of color transitions 92 a, 92b, 92 c, 92 a′, 92 b′, 92 c′ between the stripes 84, 86, 88, 90, 84′,86′, 88′, 90′ on the striped films 32, 32′, respectively, that passbetween the dies 112, 112′, for reasons which will be apparent basedupon the operation of the enrobing apparatus 102 described hereinafter.The dies 112, 112′ should be at or below room temperature and may bebrought to, or maintained at, such temperature by any suitableconventional, known temperature control means (not shown). In addition,if desired, the exterior circumferential surfaces 124, 124′, includingthe recesses 126, 126′, of each die 112, 112′, respectively, may betreated so as to reduce the tendency of the films 32, 32′ to stickthereto, such as, for example, applying a suitable conventionallubricant thereto, or coating the surfaces 124, 124′ with TEFLON® oranodizing the surfaces 124,124′.

[0123] As can be seen in FIG. 16, the orientation of the striped films32, 32′ as they pass between the rotary dies 112, 112′ is such that thered stripes 84, 88 of one film 32 are matched with the red stripes 84′,88′ of the other film 32′ and the yellow stripes 86, 90, 86′, 90′ ofeach film 32, 32′, respectively, are similarly matched with one another.The registering means 120 of the enrobing apparatus 102 may be used tofacilitate the orientation of the films 32, 32′ such that the matchingand alignment of the color transitions 92 a, 92 b, 92 c, 92 a′, 92 b′,92 c′ of each film 32, 32′, respectively, are improved.

[0124] As the dies 112, 112′ rotate, each recess 126 of one rotary die112 cooperates with a corresponding recess 126′ on the other rotary die112′ at the nip between the dies 112, 112′ to form a cavitytherebetween. The recesses 126, 126′ are sized and shaped such that thecavities formed therebetween are slightly larger than the enrobed core10, thereby preventing unnecessary contact between the films 32, 32′ andthe interior surfaces of the recesses 126, 126′. As the rotary dies 112,112′ rotate, the cores 10 are dispensed to the nip between the dies 112,112′ such that they are oriented with their lengths aligned parallel tothe axes of rotation AR, AR′ of the dies 112,112′ and each core 10 isthereby properly aligned to be received between a pair of coactingrecesses 126, 126′. The rotary dies 112, 112′ continue to rotate and thefilms 32, 32′ are sealed to each other by the raised rims 128, 128′ ofthe coacting recesses 126, 126′, around the core 10 thereby forming afilm seam 134, which lies in the transverse plane of symmetry 16 of thecore 10. The raised rims 128, 128′ also cut through the bonded films 32,32′, at the film seam 134 around each enrobed core 10, thereby releasingthe enrobed core products, or gelcaps 122, from the bonded films 32,32′.

[0125] With reference to the film seam 134 of the gelcaps 122, it isnoted that in addition to the configuration described above wherein thefilms 32, 32′ are sealed together and cut by the raised rims 128, 128′of the coacting recesses 126, 126′ thereby resulting in abutting filmedges that form the film seam 134, it is also possible to have a filmseam 134 wherein the cut edge of one film 32 slightly overlaps the cutedge of the other film 32′ by an amount approximately equal to thethickness of the films 32, 32′. Alternatively, the film seam 134 couldbe formed such that the cut edges of the films 32, 32′ are aligned withone another about the core 10, but are spaced apart slightly by adistance that is approximately equal to the thickness of the films 32,32′. Regardless of which of the foregoing types of film seams 134 (i.e.,abutting, overlapping or spaced apart) that is formed on the gelcapproduct 122, the film seam 134 lies substantially in the transverseplane of symmetry 16 of the core 10. It should be understood that theforegoing discussion of the possible types of film seams also applies toall embodiments of the present invention discussed hereinafter.

[0126] As shown in FIGS. 14 and 16, the film coatings of the resultinggelcaps 122 conform tightly and snugly to the cores 10, therebyresulting in tamper-proof gelcap products 122. In addition, theresulting gelcap product 122 is bi-colored, the film seam 134 lying inthe transverse plane of symmetry 16 of the core 10 and the colortransition 136 lying in the conjugate plane of symmetry 18 of the core10. As a result, the color transition 136 of each of the gelcaps 122 maybe flush and seamless (i.e., without any raised portion which generallycharacterizes the film seam 134). In addition, the foregoing process mayresult in gelcap products 122 having a film coating of uniform colorquality and thickness over their entire surface.

[0127] If aesthetically desired, the films 32, 32′ may be aligned suchthat the resulting gelcaps 122 have a film seam 134 wherein a stripe ofone color (for example, a red stripe 84) (or visual distinction) of onefilm 32 abuts or overlaps a stripe of another color (for example, ayellow stripe 90′) (or visual distinction) of the other film 32′ to forma gelcap 122 having a “checkerboard pattern”, i.e., having fourquadrants of alternating red and yellow colors (or other visualdistinctions) (not shown).

[0128] After being cut and released from the bonded films 32, 32′ in amanner disclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983, the gelcaps122 may be collected in collecting chutes and/or conveyors (not shown)and transported to further processing equipment (not shown) for furtherprocess steps in which the lubricants may be removed, the gelcaps 122may be dried and/or, if desired, additional coatings or identifyingmarkings may be added.

[0129] As illustrated in FIGS. 17-21, the second embodiment of thepresent invention is directed to an alternative method for producingstriped film having transversely oriented stripes, using rotary dieapparatus and process that are nearly identical to those describedabove.

[0130] With reference particularly, to FIGS. 17-19, a simplified,schematic representation is provided of an alternative film castingapparatus 136, which produces the aforesaid transversely striped film138 for enrobing cores 10 in accordance with the second embodiment ofthe present invention. More particularly, FIG. 17 shows an elevated sideview of the alternative film casting apparatus 136, while FIG. 18 showsa top plan view thereof. FIG. 19 shows an elevated front view of thealternative film casting apparatus 136, as viewed from the position ofline G-G in FIG. 18 and looking in the direction of the arrows.

[0131] Referring now to FIG. 17, the alternative film casting apparatus136 includes film receiving means, such as a conventional metal castingbelt 140 that is mounted onto two rotating drums 142, 144, for receivingthe film 138 being cast thereon, as described in further detailhereinafter. The rotating drums 142, 144 rotate at a controllable ratein the directions indicated by the arrows H and I respectively, in FIG.17, thereby causing the casting belt 140 to move in the directionsindicated by the arrows J and K. While the casting belt 140 can be madeof suitable materials other than metal that will removably receive thefilm 138 thereon, such as carbon steel or stainless steel available fromBelt Technology of Agawam, Mass., metal is the preferred material. Thesurface of the casting belt 140 may be polished to reduce the tendencyof the film 138 to stick thereon. In addition, a warming plate 148 maybe positioned adjacent to the casting belt 140 to warm the casting belt140 prior to casting film thereon, for a purpose discussed hereinafter.A cooling plate 150 is positioned adjacent to the casting belt 140 tocool the casting belt 140 after film is cast thereon, for a purpose thatis also discussed hereinafter.

[0132] As shown in each of FIGS. 17-19, the alternative film castingapparatus 136 further includes film depositing means, such as areciprocating multi-chamber slit extruder 146, for depositing the film138, in a semi-continuous manner, as described hereinafter, onto thecasting belt 138. Such extruders are conventional and well known topersons having ordinary skill in the art and are available commerciallyfrom various sources, including, but not limited to, WengerManufacturing of Kansas City, Mo. and Coperion Corporation of Ramsey,N.J. The configuration and operation of the slit extruder 146 are nearlyidentical to those of the slit extruder 38 of the first embodiment ofthe present invention. More particularly, as with the slit extruder 38previously discussed hereinabove, the reciprocating slit extruder 146includes interior partitions 152, 154, 156 that form interior chambers158, 160, 162, 164 for holding visually distinct stock film formingmaterial 166, 168 therein. As shown in FIG. 18, red stock film formingmaterial 166 is held in chambers 158, 162 and yellow stock film formingmaterial 168 is held in chambers 160, 164. A slit 170 is also provided,through which the stock film forming materials 166, 168 flow out of thechambers 158, 160, 162, 164 and onto the casting belt 140, therebycreating a striped film 138 as described hereinafter.

[0133] The reciprocating slit extruder 146 also includes supply means,such as feeder pipes 182, 184 for supplying the stock film formingmaterials 166, 168 to each of the chambers 158, 160, 162, 164 and flowcontrol means, such as a slidable gate 180 (see FIG. 19), forcontrolling the flow of the stock film forming materials 166, 168 fromthe chambers 158, 160, 162, 164. The width of the slit 170, and,thereby, the thickness of the resulting film 138, is adjusted by movingthe slidable gate 180 in the directions indicated by arrow L in FIG. 19.In addition, as with the slit extruder 38 previously discussedhereinabove, the reciprocating slit extruder 146 of the secondembodiment may be heated by conventional heating means, such as electriccoils, or coils with hot water circulating therein (not shown), for thepurpose of heating the stock film forming materials 166, 168 to aflowable liquid state, (or maintaining the stock film forming materials166, 168 at such state), such that the stock film forming materials 166,168 will flow easily out of each chamber 158, 160, 162, 164 and throughthe slit 170.

[0134] Each of the interior partitions 152, 154, 156 of thereciprocating slit extruder 146 has stripe control means, such as atapered blade edge (not shown, but similar to the tapered blade edges94, 96, 98 of the partitions 58, 60, 62 shown in FIG. 13 in connectionwith the first embodiment), to control the flow of the stock filmforming materials 166, 168 exiting the chambers 158, 160, 162, 164. Aswith the slit extruder 38 of the first embodiment, the tapered bladeedges (not shown) of the interior partitions 152, 154, 156 of thereciprocating slit extruder 146 ensure the formation of straight andconsistent color transitions 186, 188, 190 between the stripes of thefilm 138 as the film 138 is cast onto the casting belt 140.

[0135] Also similar to the slit extruder 38 of the first embodiment, thereciprocating slit extruder 146 may include a top cover 192 tofacilitate pressurizing its interior, by conventional pressurizing means(not shown), thereby promoting the flow of the stock film formingmaterials 166, 168 out of the chambers 158, 160, 162, 164.Alternatively, the reciprocating slit extruder 146 may include arotatable interior roller (not shown) positioned therein (see FIG. 11),which would also promote the flow of the stock film forming materials166, 168 out of the chambers 158, 160, 162, 164.

[0136] With reference, in particular, to FIGS. 18 and 19, one notabledifference between the slit extruder 38 of the first embodiment and thereciprocating slit extruder 146 of the second embodiment is that thereciprocating slit extruder 146 is connected to a conventional motor(not shown), in a manner that is known and familiar to those havingordinary skill in the art, such that it moves reciprocatingly in thedirections indicated by arrow M in FIG. 18. For example, suitablereciprocating mechanisms are discussed in the following two books:Sclater and Chironis, Mechanisms and Mechanical Devices Sourcebook, Ch.4 Reciprocating Mechanisms, McGraw-Hill Professional, June 2001 andJones, et al., Ingenious Mechanism, Vol. 1 Driving Mechanisms forReciprocating Parts, Industrial Press, November 1990, both of which areherein incorporated by reference.

[0137] More particularly, the reciprocating slit extruder 146 is movablebetween a first position 194 (shown in phantom in FIG. 19) and a secondposition 196 (also shown in phantom in FIG. 19), for a purpose describedin detail hereinafter. Such movement of the reciprocating slit extruder146 occurs at a constant speed and at timed intervals that arecontrolled and regulated by a combination of conventional motors (notshown) and registering means (not shown), such as those mentioned abovein connection with the first embodiment of the present invention.

[0138] Other notable differences between the slit extruder 38 of thefirst embodiment and the reciprocating slit extruder 146 relate to theoperation of the reciprocating slit extruder 146 and will becomeapparent from the following description. The operation of thealternative film casting apparatus 136, by which the transverselystriped film 138 is produced, will now be described in detail, usingFIGS. 17-19 as references.

[0139] Initially, the feeder pipes 182, 184 supply stock film formingmaterials 166, 168 of two colors, such as red and yellow, respectively,to alternate chambers 158, 160, 162, 164, respectively, of thereciprocating slit extruder 146. The conventional heating means (notshown) of the reciprocating slit extruder 146 is activated, therebyheating or maintaining the stock film forming materials 166, 168 withinthe chambers 158, 160, 162, 164 to a predetermined temperature, at whichthe stock film forming materials 166, 168 becomes or is maintained asliquid and flowable. The warming plate 148 may also be warmed to apredetermined temperature that is sufficient to maintain the aforesaidliquid and flowable characteristics of the stock material 166, 168 for abrief amount of time. The preferred temperatures for the stock material166, 168 and the warming plate 148 are determined, based upon the typeof stock material 166, 168 being used, in the same manner as describedhereinabove in connection with the first embodiment of the presentinvention.

[0140] The cooling plate 150 is cooled by conventional cooling means(not shown) to a predetermined temperature that will, at leastpartially, solidify the stock material 166, 168 upon physical contactwith the surface of the casting belt 140 to form the transverselystriped film 138, as described in further detail hereinafter. Oneskilled in the art would readily appreciate, without undueexperimentation, that the proper predetermined cooled temperature forthe cooling plate 150 will depend upon a number of factors, includingthe type and composition of the stock film forming materials 166, 168and the desired thickness of the transversely striped film 138, and maybe determined in the same manner as described earlier hereinabove inconnection with preferred temperature for the casting drum 34 of thefirst embodiment of the present invention.

[0141] After the stock film forming materials 166, 168, the warmingplate 148 and the cooling plate 150 have attained their desiredtemperatures, a portion 198 of the casting belt 140 is warmed by thewarming plate 148 and is then advanced by the rotating drums 142, 144 toa position underneath the reciprocating slit extruder 146. The slidablegate 180 is then moved to a position which opens the slit 170 to thethickness that is desired for the striped film 138. While the rotatingdrums 142, 144 and the casting belt 140 remain stationary, the stockfilm forming materials 166, 168 flow out of the chambers 158, 160, 162,164, along the tapered blade edges (not shown), through the slit 170 andonto the warmed portion 198 of the casting belt 140, which brieflymaintains the stock material 166, 168 in a substantially liquid,flowable state.

[0142] Simultaneously with the flow of the stock film forming materials166, 168 onto the casting belt 140, the reciprocating slit extruder 146is moved from its first position 194, at a constant predetermined speed,in the direction indicated by the arrow N in FIG. 19, to its secondposition 196, where it is temporarily halted. As soon as thereciprocating slit extruder 146 reaches its second position 196, theslidable gate 180 is moved to a closed position, thereby blocking theslit 170 and temporarily halting the flow of stock film formingmaterials 166, 168, which results in the formation of a film segment200. As seen in FIG. 18, the film segment 200 has alternating,transversely oriented red stripes 172, 176 and yellow stripes 174, 178with straight and consistent color transitions 186, 188, 190therebetween. The film segment 200 also has a first edge 202, a secondedge 204 and a width 206, which equals the sum of the widths of thestripes 172, 174, 176, 178.

[0143] Next, the casting belt 140 is moved by the rotating drums 142,144 in the direction shown by arrows J and K in FIG. 17, such that thefilm segment 200 is moved in the direction of the arrow J and a newlywarmed portion of the casting belt 140 is positioned beneath thereciprocating slit extruder 140. More particularly, the casting belt 140is moved until the first and second edges 202, 204 of the film segment200 are each advanced by a distance that is equal to the width 206 ofthe film segment 200, in order to make room for the casting of a secondfilm segment that will be contiguous with the first film segment 200. Itis noted that the cooling plate 150 is preferably positioned adjacentand beneath the casting belt 140 at the location to which the first filmsegment 200 is moved. Thus, the first film segment 200 is cooled whilethe second film segment is cast onto the casting belt 140. It will beappreciated by those having ordinary skill in the art, that themovements of the rotating drums 142, 144 and the casting belt 140described above can be readily maneuvered and controlled by motors (notshown) and registration devices (not shown) that are well known andconventional, as discussed hereinabove.

[0144] When it is desired to cast a subsequent film segment, with thereciprocating slit extruder 146 now in its second position 196 and thecasting belt 140 held stationary, the slidable gate 180 is again movedto a position which opens the slit 170 by an amount that is equal to thethickness desired for the striped film 138. As the stock film formingmaterials 166, 168 flow out of the chambers 158, 160, 162, 164 and ontothe casting belt 140, the reciprocating slit extruder 146 is moved fromits second position 196, at a constant predetermined speed, back to itsfirst position 194, where it is again temporarily halted. As the stockfilm forming materials 166, 168 are being cast onto the casting belt140, the first edge of the new film segment will meet and bond with thesecond edge 204 of the first film segment 200. After the reciprocatingslit extruder 146 returns to its first position 194, the slidable gate180 is again moved to its closed position, thereby blocking the slit 170and temporarily halting the flow of stock film forming materials 166,168, which results in the creation of a new film segment that is bondedto the first film segment 200.

[0145] The foregoing process steps are repeated continuously, resultingin a film casting process that is semi-continuous and which produces acontinuous ribbon of transversely striped film 138. The transverselystriped film 138 is continuously removed from the casting belt 140 by ascraper or similar, known device (not shown) and advanced in thedirection of arrow J in FIG. 17. The transversely striped film 138 isthen fed into the rotary die enrobing apparatus 102 for enrobing cores10 as described above in connection with the first embodiment of thepresent invention. It is noted that, as shown in FIG. 20, except for theorientation of the recesses 210, 210′ on the rotary dies 208, 208′ (seeFIG. 20) and the orientation of the cores 10 that are dispensed to nipbetween the rotary dies 208, 208′ (see FIG. 20) by the core dispensingmeans 118, the enrobing apparatus 102 and its method of operation remainsubstantially unchanged.

[0146] More particularly, as can be seen in FIG. 20, because thealternative film casting apparatus 136 produces film 138 having stripes172, 174, 176, 178 that are transversely oriented, the rotary dies 208,208′ of the second embodiment must have recesses 210, 210′ which areoriented such that their lengths 212, 212′ are aligned perpendicularlyto the axes of rotation AR, AR′ of their respective rotary dies 208,208′. In addition, in accordance with the second embodiment, the coredispensing means (not shown) must orient and dispense each core 10 tothe nip between the dies 208, 208′ end-first, i.e., such that one of theends 12, 14 of each caplet 10 simultaneously contacts the convergingfilms 138, 138′ as the core 10 enters the nip. In such an orientation ofthe cores 10, the color transitions 186, 188, 190, 186′, 188′, 190′ ofthe films 138, 138′, respectively, lie in the conjugate planes ofsymmetry 18 of their corresponding cores 10 as the cores 10 enter thenip and are enrobed between the rotary dies 208, 208′. In this regard,FIG. 21 (which is similar to FIG. 15) provides a visual example of theproper positioning of the cores 10, at the nip between the dies 208,208′, in between the transversely striped films 138, 138′ and relativeto the color transitions 186, 188, 190, 186′, 188′, 190′ thereof,respectively.

[0147] As shown in FIG. 20, the resulting gelcap products 214 arebi-colored, having a film seam 216 that lies in the transverse plane ofsymmetry 16 of the core 10, and having a color transition 218 that liesin the conjugate plane of symmetry 18 of the core 10. The colortransition 218 of the gelcap 214 may be flush and seamless, i.e.,without any raised portion, and the film coating may be of uniformthickness and color quality over the entire surface of the gelcap 214.If aesthetically desired, the films 138, 138′ may be aligned such thatthe resulting gelcaps 214 have a film seam 216 wherein a stripe of onecolor or visual distinction (for example, a red stripe 172) of one film138 abuts or overlaps a stripe of another color or visual distinction(for example, a yellow stripe 178′) of the other film 138′ to form agelcap 214 having a “checkerboard pattern” (not shown), i.e., havingfour quadrants of alternating red and yellow colors or other visualdistinctions.

[0148] After being cut and released from the bonded films 138, 138′ inthe same manner as disclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983,the gelcaps 214 may be collected in collecting chutes and/or conveyors(not shown) and transported to further processing equipment (not shown)for further process steps in which the lubricants may be removed, thegelcaps 214 may be dried and/or, if desired, additional coatings oridentifying markings may be added.

[0149] As illustrated in FIGS. 22-30, the third embodiment of thepresent invention is directed to an alternative enrobing apparatus (see,especially, FIGS. 22 and 26), which includes the alternative filmcasting apparatus 136 of the second embodiment and the transverselystriped film 138 produced thereby. In a process described in detailhereinafter, the transversely striped film 138 is fed, along with thecores 10, into the alternative enrobing apparatus to produce bi-coloredgelcap products, each having a film seam that only partiallycircumscribes the gelcap and which lies in a reference plane that isdifferent from the reference plane in which the color transition of thegelcap lies.

[0150] With reference initially to FIGS. 22, 23 and 26-30, thealternative enrobing apparatus in accordance with the third embodimentof the present invention includes a conveyor system 220 (see FIG. 22)that comprises a series of horizontally-oriented rollers 222 and pairsof rollers, 224, 226, 228 (see FIGS. 26-30), for supporting andconveying the transversely striped film 138. The conveyor system 220will be described in greater detail hereinafter in connection with FIG.26.

[0151] It will be recalled that the film 138 has alternatetransversely-oriented red stripes 172, 176 and yellow stripes 174, 178with color transitions 186, 188, 190 therebetween (see, e.g., FIGS. 18and 20), although, as set forth above, any stock film forming materialshaving other colors or other visual distinctions or appearances aresuitable. A core dispensing means 230 is positioned above the conveyorsystem 220 and the film 138 for the purpose of dispensing the cores 10onto the film 138 in the required orientation with respect to the colortransitions 186, 188, 190 (see, e.g., FIGS. 25A-25C).

[0152] The core dispensing means 230 includes a core hopper 232 forholding the cores 10 to be enrobed prior to their entry into a series ofslat feeders 234, 236, which are of a well-known type and arecommercially available from DT Lasko Merrill of Leominster, Mass., aswell as from Aylward Enterprises, Inc. of New Bern, N.C. and IntegratedPackaging Systems, Inc. of Parsippany, N.J. The slat feeders 234, 236typically include a series of internal brushes and wheels (not shown)that orient the cores as required for proper positioning onto the film138.

[0153] The core dispensing means 230 further includes a core positioningslat 238 and a core plunger 240, which is positioned above thepositioning slat 238 and is moved reciprocatingly in the directionsshown by the arrow P in FIG. 22 by a conventional motor (not shown),such as a hydraulic motor (not shown), in a well-known manner. Aregistering means 242 (shown schematically only in FIG. 22) is alsoincluded to assist in the proper positioning of the caplets 10 onto thefilm 138, as described hereinafter. The registering means 242 includesany one of many conventional, known types of optical sensory and controldevices (not shown, but discussed above in connection with the firstembodiment). The registering means 242 also includes conventional, knownmechanical adjusting means (not shown), such as a stepper motor (notshown), for adjusting the speed and position of the advancing film 138on the conveyor system 220, as necessary. Such stepper motors arecommercially available from various sources including, but not limitedto, Bayside of Port Washington, N.Y., and are well known to personshaving ordinary skill in the art.

[0154] The positioning slat 238, more particularly, has a pair ofexternal walls 244, 246, each with a core support rail 248, 250,respectively, one of which is shown in phantom in FIG. 22 and the otherof which is partially visible in FIG. 23. The walls 244, 246 are sizedand shaped so as to receive therebetween caplets 10 having theirtransverse planes of symmetry 16 aligned with the length of the walls244, 246, as can best be seen in FIGS. 25A-25C. The support rails 248,250 are each attached to the inner surfaces 252, 254, respectively, ofthe walls 244, 246, and are sized and shaped such that each core 10within the positioning slat 238 is slideably supported simultaneously byeach support rail 248, 250. Moreover, the walls 244, 246 are spacedapart from one another a sufficient distance such that the cores 10 arein frictional, but movable, contact with the inner surfaces 252, 254 ofthe walls 244, 246. Thus, when the cores 10 are no longer supported bythe support rails 248, 250, as described hereinafter, they aretemporarily held suspended above the conveyor system 220 and the film138.

[0155] In FIGS. 23 and 24A, it can be seen that the inner corners 256,258 of the support rails 248, 250 may be rounded to prevent gouging orother physical damage to the cores 10 as they slide therealong. It isnoted that, depending upon the configuration of the cores 10, the shapeof the inner corners 256, 258 of the support rails 248, 250 can bemodified. For example, where the cores 10 have a land 22, the innercorners need not be rounded, but rather, they may be 90-degree corners256′, 258′ (as shown in FIG. 24D).

[0156] With reference now to FIGS. 24A-24C and 25A-25C, the operation ofthe core dispensing apparatus 230, and especially the positioning slat238 and plunger 240, will now be described. It is noted that FIGS.24A-24C show the positioning slat 238, the plunger 240, the film 138 andcores 10′, 10″, as viewed from the position of line Q-Q in FIG. 22 andlooking in the direction of the arrows. FIGS. 25A-25C show side views ofa portion of the positioning slat 238, as well as the plunger 240, thefilm 138, and cores 10′, 10″, as seen from within the positioning slat238 (i.e., as if the nearest wall 244 and corresponding support rail 248were eliminated).

[0157] During continuous operation, which is the preferred mode ofoperation in accordance with the third embodiment of the presentinvention, the cores 10 are fed from the hopper 232, through the slatfeeders 234, 236, to the positioning slat 238, in a known manner. Asthey are fed into the positioning slat 238, the cores 10′, 10″, 10′″ arelined up, end 12 to end 14, as shown in FIGS. 25A-25C and 26, and,thereby, each core 10′, 10″, 10′″ is moved along the positioning slat238 in a substantially continuous manner by the core behind it.

[0158] When a core 10′ is pushed beyond the support rails 248, 250 andis no longer supported thereby, and when the position of a colortransition 186 of the film 138 lies in the conjugate plane of symmetry18′ of the core 10′, the registering means 242 signals the motor (notshown), which the moves the plunger 240 in the direction shown by thearrows R, R′ in FIGS. 24A and 25A, respectively. The plunger 240 movesin the direction of the arrows R, R′ until the core 10′ contacts andrests upon the film 138 (see FIGS. 24B and 25B), whereupon the plunger240 momentarily stops its descent and is then moved in the oppositedirection, shown by the arrows S, S′ in FIGS. 24B and 25B, respectively.When the plunger 240 reaches its upmost position, as shown in FIGS. 24C,25C, it momentarily stops, until the next core 10″ is moved beyond thesupport rails 248, 250. The foregoing events are repeated continuouslyas long as cores 10 are fed and moved through the positioning slat 238.

[0159] With reference now, in particular, to FIGS. 26-30, the remainingcomponents of the alternative enrobing apparatus of the thirdembodiment, as well as their operation, will now be described. Moreparticularly, FIG. 26 shows a schematic perspective view of thepositioning slat 238, the conveyor system 220 having specialized rollers222 and pairs of rollers 224, 226, 228 and a pair of rotary dies 260,262. It is noted that the rotary dies 260, 262 are similar, but notidentical, to the rotary dies 112, 112′, 208, 208′ of the first andsecond embodiments discussed earlier hereinabove. As seen in FIG. 26,the rollers 222 and the pairs of rollers 224, 226, 228 of the conveyorsystem 220 are arranged side-by-side.

[0160] More particularly, the beginning portion of the conveyor system220, i.e., the portion that is located between the alternative filmcasting apparatus 136 (shown only partially in FIG. 22, see FIG. 17 forfull view) and a short distance on the opposite side of the corepositioning slat 238 (see FIG. 26), is comprised ofhorizontally-oriented rollers 222. FIG. 27 shows an elevational end viewof a core 10, the film 138 and a horizontally-oriented roller 222, intheir relative positions to one another, as seen from the position ofline T-T in FIG. 26 and looking in the direction of the arrows.

[0161] The film 138 is moved by the horizontally-oriented rollers 222(see FIG. 22), from the alternative film casting apparatus 136 to ashort distance past the positioning slat 238 and plunger 240, by whichcores 10 have already been deposited onto the film 138, as describedhereinabove. It is noted that the horizontally oriented rollers 222should be at least as long as the width of the film 138, to ensuresufficient support for the film 138. The horizontally-oriented rollers222 may spin about their longitudinal axes 264 in the direction shown bythe arrow U in FIG. 27.

[0162] As shown in FIG. 26, the remaining portion of the conveyor system220, which is located between a short distance past the positioning slat238 and the rotary dies 260, 262, is comprised of pairs of rollers 224,226, 228, rather than the horizontally-oriented rollers 222. As shownschematically in FIG. 26, the individual rollers of sequential pairs ofrollers 224, 226, 228 are gradually and sequentially pivoted upward fromthe horizontal plane, in increments of about 10 degrees for eachsuccessive pair of rollers 224, 226, 228, starting proximate to thepositioning slat 238, such that, as the film 138 approaches the rotarydies 260, 262, the film 138 is folded longitudinally about the cores 10.

[0163] More particularly, the individual rollers 224 a, 224 b of thepairs of rollers 224 that are located proximately to the positioningslat 238 are pivoted upward a small amount, i.e., about 30 degrees (seeFIG. 28 showing the degree to which the individual rollers 224 a, 224 bat this location are pivoted, as seen approximately from the position ofline V-V in FIG. 26 and looking in the direction of the arrows). Asshown in FIG. 28, the individual rollers 224 a, 224 b in these pairs 224may each spin about their longitudinal axes 266 a, 266 b in thedirections indicated by the arrows Wa, Wb.

[0164] By comparison, the individual rollers 226 a, 226 b of the pairsof rollers 226 that are located further from the positioning slat 238are pivoted upward by a greater amount, i.e., about 70 degrees (see FIG.29 showing the degree to which the individual rollers 226 a, 226 b atthis location are pivoted, as seen from the position of line X-X in FIG.26 and looking in the direction of the arrows). As shown in FIG. 29, theindividual rollers 226 a, 226 b in these pairs 226 each spin about theirlongitudinal axes 268 a, 268 b in the directions indicated by the arrowsYa, Yb.

[0165] Lastly, as shown in FIGS. 26 and 30, the individual rollers 228a, 228 b of the pairs of rollers 228 which are proximate to the rotarydies 260, 262 are configured differently from the other individualrollers 224 a, 224 b, 226 a, 226 b. More particularly, the individualrollers 228 a, 228 b of these pairs of rollers 228 each have a concavecentral portion 270 a, 270 b which cooperate to form an opening 272therebetween that is sized and shaped to allow the film 138 and cores 10to pass snugly therethrough. Each individual roller 228 a, 228 b alsohas a cylindrical upper portion 274 a, 274 b which cooperate with oneanother to press the longitudinal edges 276, 278 of the film 138 againstone another (see FIG. 30), thereby bonding the longitudinal edges 276,278 of the film 138 to one another prior to passing through the rotarydies 260, 262. FIG. 30 shows that the individual rollers 228 a, 228 b ofthe pairs of rollers 228 at this location are oriented substantiallyvertically, as seen from the position of line Z-Z in FIG. 26 and lookingin the direction of the arrows. As also shown in FIG. 30, the individualrollers 228 a, 228 b of these pairs of rollers 228 may each rotate abouttheir longitudinal axes 280 a, 280 b in the directions indicated by thearrows AAa, AAb.

[0166] It is noted that different configurations are possible for theindividual rollers 224 a, 224 b, 226 a, 226 b, 228 a, 228 b and thepairs of rollers 224, 226, 228, for example, one roller 224 a, 226 a,228 a in each pair could be horizontally positioned and remainstationary, while the other roller 224 b, 226 b, 228 b in each pair ispivoted. In addition, depending upon the support requirements of thefilm 138, greater or fewer numbers of horizontally-oriented rollers 222and pairs of rollers 224, 226, 228 may be used for the conveyor system220 and they may be spaced more closely or further apart than shown inthe accompanying figures.

[0167] The rotary dies 260, 262 of the third embodiment of the presentinvention, shown in FIG. 26, are similar to the rotary dies 112, 112′,208, 208′ of the first and second embodiments in that they rotate in thedirections indicated by the arrows BB and CC, respectively, in FIG. 26,thereby cooperating with one another to form a nip therebetween, intowhich the cores 10 and the film 138 are fed. Likewise, each of the dies260, 262 have recesses 282, 284, arranged circumferentially in a row onthe surface of each die 260, 262. The recesses 282, 284 each have raisedrims (not shown) for sealing and cutting the bonded film 138 about thecores 10, thereby enrobing the cores 10 to form gelcap products 286.

[0168] The rotary dies 260, 262 of the third embodiment, however, areoriented such that they rotate in the horizontal plane, rather than inthe vertical plane as do the previously discussed rotary dies 112, 112′,208, 208′. Furthermore, when the cores 10 are fed into the nip betweenthe dies 260, 262 of the third embodiment, the film 138 is folded andpartially bonded about them. Furthermore, the partially enrobed caplets10 are fed successively, i.e., one-by-one, into the nip between the dies260, 262.

[0169] The gelcap products 286 of the third embodiment are similar tothe gelcaps 122, 214 of the previous embodiments, in that they aregelcaps 286 having at least two visually distinct, or differentlycolored, portions and having film seams 288 which are transverselyoriented relative to the color transitions 290 (or other visualdistinction transitions) of the gelcaps 286. More particularly, the filmseam 288 lies in the transverse plane of symmetry 16 of the core 10 andthe color transition 290 lies in the conjugate plane of symmetry 18 ofthe core 10. In addition, in contrast to gelcaps produced by apparatusand methods of the prior art, the color transition 290 of the gelcap 286of the third embodiment may be flush and seamless, i.e., without anyraised portion which generally characterizes the film seam 288 ofgelcaps. Moreover, the gelcaps 286 may have a film coating of uniformcolor quality and thickness over their entire surface. It is noted,however, that unlike the gelcaps 122, 214 of the previously describedembodiments, the film seams 288 of the gelcaps 286 that are produced bythe apparatus and process of the third embodiment extend only partiallyabout the cores 10. If aesthetically desired, the film 138 may overlapslightly at its edges along the film seam 288.

[0170] As will be appreciated by those persons with ordinary skill andexperience in the present field, it is possible to substitute otherknown, conventional cutting devices in place of the rotary dies 260, 262shown in FIG. 26. For example, die punches (not shown), or reciprocatinguniplasts (not shown), having recesses or cutouts that are sized andshaped to receive therein the partially enrobed caplets 10 could beused. Such devices are commercially available from various sources,including, but not limited to, The Irwin-Hodson Company of PortlandOreg., and are well-known to those having ordinary skill in the art. Inaddition, alternative reciprocating cutting apparatus which relates toproducing enrobed capsule products is disclosed in U.S. Pat. No.6,352,719, which is hereby incorporated by reference herein.

[0171] With reference to the movement of the transversely striped film138 along the conveyor system 220 of horizontally-oriented rollers 222and pairs of rollers 224, 226, 228, it is noted that the film 138 isencouraged to move, continuously and at a substantially constant speed,in the direction of the arrow DD in FIG. 26, by the nip between therotary dies 260, 262 and the momentum of the horizontally-orientedrollers 222 and the pairs of rollers 224, 226, 228 as they spin abouttheir axes. Alternatively, or in addition thereto, one or more of thehorizontally-oriented rollers 222 and the pairs of rollers 224, 226, 228could be mechanized by conventional motors (not shown) to spinautonomously, thereby encouraging the film 138 to move along theconveyor system 220 toward the rotary dies 260, 262.

[0172] With reference to the stock film forming material that is used inconnection with the foregoing alternative core enrobing apparatus of thethird embodiment, when it is either thermoplastic starch-based materialor cellulose-based material, as suggested hereinabove, the transverselystriped film 138 must be heated prior to being advanced along theportion of the conveyor system 220 that is comprised of pivoted pairs ofrollers 224, 226, 228 to ensure that the film 138 is sufficientlyformable and malleable to be folded about the caplets 10 by the pairs ofrollers 224, 226, 228, while maintaining its physical integrity. In suchcircumstances, the film 138 can be heated by conventional heating means,such as, for example, a resistive heating device (not shown) which wouldheat the film 138 indirectly by heating selected horizontally-orientedrollers 222 and pairs of rollers 224, 226, 228, or hot air blowers (notshown) which could heat the film 138 directly by blowing hot airthereon. Suitable heaters are commercially available, for example, fromChromolox, Inc. of Pittsburgh, Pa. and Watlow Electric ManufacturingCompany of St. Louis, Mo. Suitable hot air blowers are commerciallyavailable, for example, from New York Blower Company of Willowbrook,Ill. and Niagara Blower Company of Buffalo, N.Y.

[0173] More particularly, where the film 138 is made of starch-basedmaterial, the film 138 should be heated to between about 50 degreesCelsius and about 150 degrees Celsius and where the film 138 is made ofcellulose-based material, the film 138 should be heated to between about80 degrees Celsius and about 120 degrees Celsius.

[0174] The fourth embodiment of the present invention, which relates toa vacuum forming apparatus and method of enrobing cores is generallyillustrated in FIGS. 31-43. It is noted that, while various types ofthermal formable films, including films made of the previously discussedgelatin-, starch- and polymer-based materials, may be used in connectionwith the fourth embodiment of the present invention, films made ofcellulose ether-based materials, e.g. hydroxypropyl methylcellulose, arethe preferred films to be used in connection with the apparatus andmethod described hereinafter. However, while the composition of the filmmay be the same or similar to that of the films discussed hereinabove,the film that is used in connection with the apparatus of the fourthembodiment is pre-manufactured as a dry film, rather than the wet filmsthat were described previously in connection with the first, second andthird embodiments.

[0175] More particularly, to produce films that are suitable for usewith the vacuum forming apparatus of the fourth embodiment, the wetfilms of the previous embodiments are subjected to a further dryingstep, which involves heating the film, in a manner that is well-known tothe art of film forming, to a temperature such that the film remainspliable, but no longer automatically bonds to itself upon contact. Thedried film is then mounted onto rollers, as shown and describedhereinafter in connection with FIG. 31. In addition, the dry films usedin this fourth embodiment may also be subjected to further processingsteps, including, but not limited to, the addition of humectants orplasticizers, such as glycerin or sorbitol, for the purpose of enhancingthe elasticity and formability of the dry films. For example, from 0.1to 10 weight percent of humectants, based upon the total weight of thedry film material, could be added to the dry films. In addition, from 5to 50 weight percent of plasticizers, based upon the total weight of thedry film material, could be added to the dry films. It is also notedthat, as discussed hereinafter, striped films having stripes that areeither longitudinally or transversely oriented may be used in connectionwith the apparatus and method of the fourth embodiment, which will nowbe described in detail. Films having a thickness of between about 0.01millimeters and about 0.5 millimeters are most suitable for use inconnection with this fourth embodiment of the present invention.

[0176] With reference, in particular, to FIG. 31, a schematicelevational side view is provided of the vacuum forming apparatus 292 ofthe fourth embodiment. More particularly, the vacuum forming apparatus292 includes a first plurality of individual porous platens 294, as wellas a first conveyor system 296 and a second conveyor system 298. Asshown schematically in FIG. 31, the first and second conveyor systems296, 298 are arranged in series with one another, thereby creating asingle path, indicated by the arrows EE, FF, along which the first andsecond conveyor systems 296, 298 move each of the porous platens 294 insemi-continuous fashion. For purposes of illustration only, the firstand second conveyor systems 296, 298 are shown schematically in FIG. 31mounted on tables 296′, 298′. In addition, the first and second conveyersystems 296, 298 are provided with conventional vacuum sources 300, 302,respectively, (shown only schematically in FIG. 31) that apply a vacuumto each of the porous platens 294 while they are moved in the directionshown by the arrow EE, for a purpose to be discussed hereinafter.Suitable conventional vacuum sources, such as vacuum pumps, would becommercially available from, for example, The Nash Company of Trumbull,Conn. and Gast Manufacturing of Benton Harbor, Mich.

[0177] It is noted that the first and second conveyor systems 296, 298each include a conveyor mechanism, such as a conventional chain track(not shown) or other conventional mechanism of a type that is known inthe art. More particularly, conveyor systems suitable for use inconnection with the vacuum forming apparatus 292 of the presentinvention are typically custom manufactured and persons having ordinaryskill in the art will be familiar with the basic configuration andoperation of such devices. Suitable conveyor systems are currentlycommercially available from, for example, Dorner of Hartland, Wis.

[0178] With reference still to FIG. 31, the vacuum forming apparatus 292further includes a second plurality of individual porous platens 304 anda third conveyor system 306 that moves these porous platens 304 along asecond path, which is shown by the arrow GG in FIG. 31. It is noted thatthe third conveyor system 306 is positioned between the first and secondconveyor systems 296, 298 for a purpose that is clarified hereinafter.

[0179] A rotating mechanism 308 (shown only schematically in FIG. 31) ispositioned between the first and second conveyor systems 296, 298. Therotating mechanism 308 is a conventional device and well known topersons having ordinary skill in the art. The rotating mechanism 308 isdesigned to simultaneously hold together two of the platens, i.e., oneplaten 294 and a corresponding platen 304, and rotate them together,such that the platen 304 that is first on top is inverted and thenpositioned on the bottom after the rotation is completed. The aforesaidrotation will be described in further detail hereinafter.

[0180] Except for their opposite orientations, the porous platens 294,304 are essentially identical to one another. More particularly, asshown in phantom in certain of the porous platens 294, 304 in FIG. 31,each porous platen 294, 304 has at least one recess 310, 312,respectively, on a working surface 314, 316, respectively, thereof. Eachrecess 310, 312 is sized and shaped to temporarily but snugly receivetherein a caplet 10 to be enrobed. With reference to FIGS. 33 and 35, itis noted that, although the porous platens 294, 304 are shown in FIG. 31as each having a single longitudinally oriented recess 310, 312, it isnoted that the porous platens 294, 304 may be configured to each have aplurality of recesses 310, 312. For example, the platens 294, 304 couldeach be long enough to include a single row of recesses 310, 312, or, asshown in FIGS. 33 and 35, each platen 294 a, 294 b could be long andwide enough to have multiple rows of recesses 310 a, 310 b.

[0181] In addition, it is noted that, if the orientation of the recesses310 a, 310 b of the platens 294 a, 294 b is varied, the use ofdifferently striped films can be accommodated, as follows. Withreference to FIGS. 32 and 33, where the recesses 310 a are orientedlongitudinally on the working surface 314 a of the porous platen 294 a(see FIG. 33) it is possible to use a striped film 318 havingalternating colors or visual distinctions, e.g., red and yellowtransverse stripes 320, 322 (see FIG. 32), to produce gelcap productshaving a color transition (or other visual distinction transition) thatlies in the conjugate plane of symmetry 18 of the core 10. The resultingproduct would resemble gelpcaps 122, 214, 286 produced in connectionwith the previously discussed embodiments of the present invention. InFIGS. 32 and 33, the transversely striped film 318 is shown suspendedabove the platen 294 a in the proper position relative to the recesses310 a, such that the color transitions 324, 326 between the transversestripes 320, 322 are properly aligned with the recesses 310 a to resultin the production of the aforesaid bi-colored enrobed core products.

[0182] With reference to FIGS. 34 and 35, on the other hand, it ispossible for the recesses 310 b to be oriented transversely on theworking surface 314 b of the porous platen 294 b (see FIG. 35) toaccommodate the use of a striped film 328 having alternating colors orvisual distinctions, e.g., red and yellow longitudinal stripes 330, 332(shown in FIG. 34), to produce gelcap products having a color transitionlying in the conjugate plane of symmetry 18 of the core 10. In FIGS. 34and 35, the longitudinally striped film 328 is shown suspended above theplaten 294 b in the proper position relative to the recesses 310 b, suchthat the color transitions 334, 336 between the longitudinal stripes330, 332 are properly aligned with the recesses 310 b to result in theproduction of the aforesaid bi-colored caplet products.

[0183] It is of course possible to achieve multi-colored gelcap productshaving color transitions oriented in a variety of different ways usingdifferent combinations of the platens 294 a, 294 b shown in FIGS. 33 and35, with transversely and longitudinally striped films 318, 328, shownin FIGS. 32 and 34. In this regard, however, it is noted that, within aparticular vacuum forming apparatus, the orientation of the recesses310, 312 in all of the platens 294, 304 must be longitudinal, or,alternatively, the orientation of the recesses 310, 312 in all of theplatens 294, 304 must be transverse (or otherwise aligned with theorientation of the stripes on the films).

[0184] With reference again to FIG. 31, the vacuum forming apparatus 292further includes a first pair of rollers 338, 340 having a first stripedfilm 342 mounted thereon. As shown in FIG. 31, the first pair of rollers338, 340 is positioned proximate to the first conveyor system 296 suchthat the first striped film 342 is suspended above the first pluralityof porous platens 294, which are being moved thereon along the pathshown by the arrow EE. A second pair of rollers 344, 346 having a secondstriped film 348 mounted thereon is also provided. Like the first pairof rollers 338, 340, the second pair of rollers 344, 346 is positionedproximate to the second conveyor system 298 such that the second stripedfilm 348 is also suspended above the first plurality of porous platens294, which are being moved thereon along the path shown by the arrow EE.

[0185] It is noted that, in order to produce gelcaps having a colortransition, or transition between other visually distinct portions ofthe enrobed core 10, that lies in the conjugate plane of symmetry 18 ofthe core 10 using platens 294 a like those of FIG. 33 >(i.e., all havinglongitudinally oriented recesses 310 a), both the first and secondstriped films 342, 348 must have transversely oriented stripes 320, 322,as shown in FIG. 32. Similarly, in order to produce bi-colored gelcapsstill having a color transition that lies in the conjugate plane ofsymmetry 18 of the caplet 10 using platens 294 b like those of FIG. 35(i.e., all having transversely oriented recesses 310 b), it would benecessary for both the first and second striped films 342, 348 to havelongitudinally oriented stripes, as shown in FIG. 34.

[0186] The above-described variations concerning the orientation of therecesses 310, 312 on the platens 294, 304 and the orientation of thestripes on the first and second films 342, 348 are all equally valid.However, for purposes of illustrating the fourth embodiment of thepresent invention in as simple and clear a manner as possible,henceforth, it will be understood that the platens 294, 304 of thevacuum forming apparatus 292 each have a single longitudinally orientedrecess 310, 312 thereon. Furthermore, it will henceforth also beunderstood that the first and second striped films 342, 348 both havealternating red and yellow stripes that are transversely oriented.

[0187] As shown in FIG. 31 and discussed in further detail hereinafter,the vacuum forming apparatus 292 also includes a first registeringdevice 350 positioned proximate to the first conveyor system 296 forproperly positioning the first transversely striped film 342 relative toa core 10 that is positioned within the recess 310 of the porous platen294, as will be described hereinafter. A second registering device 352is positioned proximate to the second conveyor system 298 for properlypositioning the second transversely striped film 348 relative to apartially enrobed caplet 10 that is positioned within the recess 310 ofanother of the porous platens 294, as will be described hereinafter. Theregistering devices 350, 352 are of the same commercially available typeas were described previously above in connection with the firstembodiment of the present invention.

[0188] As shown in FIGS. 31, 36-38 and 41-43, the vacuum formingapparatus 292 of the fourth embodiment also includes a first ring press354 and a first film cutter 356 that are positioned proximate to thefirst conveyor system 296, for purposes that will be clarifiedhereinafter. Additionally, a second ring press 358 and a second filmcutter 360 are positioned proximate to the second conveyor system 298,also for purposes that will be clarified hereinafter. More particularly,with reference to FIGS. 36-37 and 41-42, the first and second ringpresses 354, 358 are virtually identical to one another, each having anopen configuration, such as an O-shape or an oval shape, as viewed fromabove, such that there is formed a passageway 362, 364, respectively,therethrough. Each of the ring presses 354, 358 also has a contactingedge 366, 368, respectively, that is configured to contact the first andsecond films 342, 348, respectively, without damaging them. Each of thering presses 354, 358 is sized and shaped such that the contacting edges366, 368 circumscribe a core 10 therein. The first and second ringpresses 354, 358 move reciprocatingly in the directions shown by thearrows HH, II, respectively, in FIG. 31.

[0189] With reference, in particular, to FIGS. 38 and 43, the first andsecond film cutters 356, 360 are virtually identical to one another,each having a recess 370, 372, respectively, that is sized and shaped toreceive therein a portion of a partially enrobed core 10 which alreadyhas a film coating applied thereto. Each recess 370, 372 iscircumscribed by a tapered cuffing edge 374, 376 that is sized andshaped to closely circumscribe the periphery of the aforesaid partiallyenrobed core 10 and is capable of cutting neatly and cleanly through thefirst and second transversely striped films 342, 348, respectively. Thefirst film cutter 356 is oriented such that its recess 370 and cuttingedge 374 both face the porous platen 294 positioned thereunder.Similarly, the second film cutter 360 is oriented such that its recess372 and cutting edge 376 also both face the porous platen 304 positionedthereunder. Also, like the ring presses 354, 358, the first and secondfilm cutters 356, 360 move reciprocatingly in the directions shown bythe arrows HH, II in FIG. 31.

[0190] With reference still to FIG. 31, it is noted that the firsttransversely striped film 342 is mounted onto a first pair of rollers338, 340 and stretched therebetween, such that the first film 342 ispositioned between the first conveyor system 296 and the first pluralityof porous platens 294 on one side, and the first ring press 354 and thefirst film cutter 356 on the other side. Similarly, the secondtransversely striped film 348 is mounted onto a second pair of rollers344, 346 and stretched therebetween, such that the second film 348 ispositioned between the second conveyor system 298 and the firstplurality porous platens 294 on one side, and the second ring press 360and the second film cutter 362 on the other side.

[0191] As will be referred to subsequently herein, in connection withthe description of the method of the fourth embodiment, the vacuumforming apparatus 292 shown in FIG. 31 includes at least seven stations378, 380, 382, 384, 386, 388, 390 (shown in dotted lines in FIG. 31),each of which is shown in further detail in FIGS. 36-43. The aforesaidstations 378, 380, 382, 384, 386, 388, 390 show the general locations ofthe ring presses 354, 358, and the film cutters 356, 360, relative tothe other components of the vacuum forming apparatus 292. The stations378, 380, 382, 384, 386, 388, 390 also provide a conceptualrepresentation of the seven basic steps of the method of the fourthembodiment.

[0192] The operation of the vacuum forming apparatus 292 and the methodof the fourth embodiment of the present invention will now be describedin detail, with reference to FIGS. 31 and 36-44. In this regard, it isnoted that FIGS. 36-44 show elevational cross-sectional views of certaincomponents of the vacuum forming apparatus 292. More particularly, thecross-sections of the platens 294, the first ring press 354 and thefirst film cutter 356 shown in FIGS. 36-39 are taken along cross-sectionline JJ-JJ of FIG. 31 and are viewed from the same direction as whenviewing the vacuum forming apparatus 292 shown in FIG. 31. Thecross-sections of the platens 304, the second ring press 358 and thesecond film cutter 360 shown in FIGS. 40-43 are taken alongcross-section line KK-KK of FIG. 31 and are also viewed from the samedirection as when viewing the vacuum forming apparatus 292 shown in FIG.31. It is further noted that the conveyor systems 296, 298, theregistering devices 350, 352 and the vacuum sources 300, 302 are omittedfrom FIGS. 36-43 to simplify the description of the operation of thevacuum forming apparatus 292, by which cores 10 are enrobed with thefirst and second transversely striped films 342, 348.

[0193] Initially, the first, second and third conveyor systems 296, 298,306 are set into motion, thereby moving the porous platens 294, 304 inthe directions indicated by the arrows EE, FF, GG, respectively, in FIG.31. The vacuum sources 300, 302 are also activated, thereby applyingvacuums, in the range of about 0.005 Torr to about 700 Torr, to thefirst and second conveyor systems 296, 298, and, thereby in turn, toeach of the first plurality of porous platens 294 that is being moved inthe direction of the arrow EE.

[0194] More specifically, with reference initially to FIG. 31, the firstconveyor system 296 moves one of the porous platens 294 to a positionthat is immediately prior to the first station 378. A core 10 is placedinto the recess 310 of this porous platen 294 by a core dispensingmechanism (not shown). It is noted that the core dispensing mechanism ofthis fourth embodiment can be any one of conventional, well-known coredispensing mechanisms, such as those described previously in connectionwith the first, second and third embodiments. The core 10 is held firmlyin the recess 310 by the aforementioned vacuum, which is continuouslyapplied to the platen 294 and all others on the conveyor 298, by thefirst vacuum source 300.

[0195] With reference now to both of FIGS. 31 and 36, the platen 294 isnext moved by the first conveyor system 296 to the first station 378.Movement of the platen 294 ceases temporarily when the first registeringdevice 350 (see FIG. 31) confirms that the core 10 is properlypositioned relative to the first striped film 342, i.e., such that thecolor transition 392 of the first striped film 342 (see FIG. 36) lies inthe conjugate plane of symmetry 18 of the core 10.

[0196] While the platen 294 is momentarily stationary, hot air is blown,by conventional, well-known means, such as a combined coil heater andfan device (not shown), through the passageway 362 of the first ringpress 354, in the direction shown by the arrows LL in FIG. 36, therebysoftening the first film 342 to a formable state. The hot air should,preferably, be in the range of between about 50 degrees Celsius and isabout 300 degrees Celsius, depending upon the type of film used. Thefirst ring press 354 is then moved in the direction shown by the arrowMM in FIG. 36, such that the contacting edge 366 of the first ring press354 presses the first film 342 onto the working surface 314 of theplaten 294 and into contact with the top half of the core 10.

[0197] As shown in FIG. 37, the heated first film 342 is simultaneouslypulled onto the core 10 and thereby made to conform to the shape of thetop half of the core 10 by the aforementioned vacuum that is applied tothe platen 294 by the first vacuum source 300. The vacuum applied by thefirst vacuum source is in the aforesaid range of about 0.005 Torr toabout 700 Torr. Thereafter, the first ring press 354 is moved away fromthe platen 294, in the direction shown by the arrow NN in FIG. 37, whilethe heated first film 342 is held onto the core 10 by the aforesaidvacuum.

[0198] With continued reference to FIG. 37, after the first ring press354 is retracted, the platen 294, having the partially enrobed core 10held in its recess 310 by the vacuum, is moved to the second station 380of the vacuum forming apparatus 292, where it is temporarily stopped.While the platen 294 and the core 10 are temporarily stationary, coldair is blown onto the first film 342 and core 10 in the direction shownby the arrows LL in FIG. 37, thereby cooling and molding the first film342 into conformity with the top half of the core 10. The cold airshould be at a temperature that is sufficiently cool to stiffen the film342 such that it retains its shape in conformity with the shape of thecore 10, more particularly between about −10 degrees Celsius and about25 degrees Celsius.

[0199] With reference now to FIG. 38, after sufficient time has passedto cool and mold the first film 342 onto the core 10, the platen 294 andpartially enrobed core 10 are moved a predetermined distance by thefirst conveyor system 296 to the third station 382 of the vacuum formingapparatus 292 and temporarily halted there such that the partiallyenrobed core 10 is aligned with the recess 370 and the cutting edge 374of the first film cutter 356. As shown in FIG. 38, the first film cutter356 is moved in the direction of the arrow OO until the partiallyenrobed core 10 is received snugly within the recess 370 and the taperedcutting edge 374 contacts and cuts through the first film 342 closelyaround the perimeter of the partially enrobed core 10. The first filmcutter 356 is then moved away from the platen 294 in a directionopposite the direction indicated by the arrow OO and scrap portions 394,396 of the first film 342 are removed from the platen 294.

[0200] With reference now to FIGS. 39 and 40, the platen 294 andpartially enrobed core 10 are next moved to the fourth, or rotating,station 384 of the vacuum forming apparatus 292 and, again, temporarilystopped, whereupon the partially enrobed core 10 is transferred to oneof the platens 304, as follows. As shown in FIG. 39, the third conveyorsystem 306 moves one of the platens 304 into position at the rotatingstation 384, such that it 304 is inverted relative to the platen 294carrying the partially enrobed core 10 thereon. It is noted that theworking surfaces 314, 316 of the platens 294, 304 are facing one another(see FIGS. 31, 39 and 40). After the platen 294 is moved a predetermineddistance, such that the partially enrobed core 10 is aligned with therecess 312 of the inverted platen 304, the first conveyor system 296holds the platen 294 and partially enrobed core 10 temporarilystationary at the rotating station 384. The platen 304 is then movedtoward the partially enrobed core 10 (i.e., in the direction shown bythe arrow PP in FIG. 39) until the partially enrobed core 10 is heldwithin the recesses 310, 312 of both of the platens 294, 304 (as shownin FIGS. 31 and 40). The vacuum being applied to the porous platen 294is discontinued and the rotating mechanism 308 (shown schematically inFIG. 31) rotates the platens 294, 304, with the partially enrobed core10 therebetween, in the direction shown by the arrows QQ, QQ′ in FIGS.31 and 40, whereupon the platen 294 holding the core 10 is inverted, andthe platen 304 is moved into a right-side-up position. The now invertedplaten 294 is now moved away from the right-side-up platen 304 andbecomes one of the platens 304 moving along the path shown by the arrowGG in FIG. 31. The right-side-up platen 304 is next moved onto thesecond conveyor system 298 and becomes one of the platens 294 movingalong the path shown by the arrows EE, FF in FIG. 31. Next, the secondvacuum source 302 applies a vacuum, in the aforesaid range of about0.005 Torr to about 700 Torr, to the partially enrobed core 10, therebyholding the partially enrobed core 10 within the recess 310 of theplaten 294, which is now moving on the second conveyor system 298, suchthat the uncovered portion of the partially enrobed core 10 is exposed.

[0201] FIGS. 41-43 show, schematically, the method by which theuncovered portion of the core 10 is covered by the second transverselystriped film 248. More particularly, with reference in particular toFIG. 41, the platen 294 and partially enrobed core 10 are moved by thesecond conveyor system 298 to the fifth station 386 of the vacuumforming apparatus 292. Movement of the platen 294 ceases temporarilywhen the second registering device 352 (see FIG. 31) confirms that thepartially enrobed core 10 is properly positioned relative to the secondstriped film 248, i.e., such that the color transition 398 of the secondstriped film 348 (see FIG. 41) lies in the conjugate plane of symmetry18 of the partially enrobed core 10.

[0202] While the platen 294 is momentarily stationary, hot air is blown,by conventional, well-known means, such as a combined coil heater andfan device (not shown), through the passageway 364 of the second ringpress 358, in the direction shown by the arrows RR in FIG. 41, whichsoftens the second film 348 to a formable state. The hot air ispreferably in the aforesaid range of about 50 degrees Celsius to about300 degrees Celsius. The second ring press 358 is then moved in thedirection shown by the arrow SS in FIG. 41, such that the contactingedge 368 of the second ring press 358 contacts and presses the secondfilm 348 onto the working surface 314 of the platen 294 and into contactwith the uncovered portion of the partially enrobed core 10.

[0203] As shown in FIG. 42, the heated second film 248 is then pulledonto the core 10 by the vacuum that is applied by the second vacuumsource 302 (see FIG. 31), in the aforesaid range of about 0.005 Torr toabout 700 Torr, to the platen 294, thereby conforming the second film248 to the shape of the uncovered portion of the core 10. Thereafter,the second ring press 358 is moved away from the platen 294, in thedirection shown by the arrow TT in FIG. 42, while the heated second film248 is held onto the core by the aforesaid vacuum applied by the secondvacuum source 302.

[0204] With continued reference to FIG. 42, after the second ring press358 is retracted, the platen 294, having the enrobed core 10 held in itsrecess 310 by the vacuum, is now moved to the sixth station 388 of thevacuum forming apparatus 292 and temporarily stopped there. It is notedthat, as shown in FIG. 42, the second film 348 partially overlaps thecut edge of the first film 342 that has already been applied to the core10. While the platen 294 and the core 10 are temporarily stationary,cold air, in the aforesaid range of about −10 degrees Celsius to about25 degrees Celsius, is now blown onto the second film 248 and core 10 inthe direction shown by the arrows RR in FIG. 42, thereby cooling andmolding the second film 348 into conformity with the core 10.

[0205] With reference now to FIG. 43, after sufficient time has passedto cool and mold the second film 348 onto the core 10, the platen 294and the enrobed core 10 are moved a predetermined distance by the secondconveyor system 298 to the seventh station 390 of the vacuum formingapparatus 292 and temporarily halted there such that the enrobed core 10is aligned with the recess 372 and the cutting edge 376 of the secondfilm cutter 360. As shown in FIG. 43, the second film cutter 360 ismoved in the direction of the arrow UU until the enrobed core 10 isreceived snugly within the recess 372 and the cutting edge 376 contactsand cuts through the second film 248 closely around the perimeter of theenrobed core 10. The second film cutter 360 is then moved away from theplaten 294 in a direction opposite the direction indicated by the arrowUU in FIG. 43.

[0206] As shown in FIG. 44, scrap portions 400, 402 of the second film344 are removed from the platen 294. The platen 294 and fully enrobedcore 10 are moved by the second conveyer system 298 away from theseventh station 390. After the platen 294 and enrobed core 10 are pastthe seventh station 390, the vacuum being applied to the platen 294 isceased, thereby releasing the enrobed caplet product, or gelcap 404 fromthe recess 310.

[0207] As shown in FIG. 44, the resulting gelcaps 404 have film coatingsthat conform tightly and snugly to the cores 10. It is noted that, inorder to form a tamperproof seal between the first and second films 342,348 and the core 10, an adhesive, such as a liquid form of the stockmaterial, can be applied to the surfaces 406, 408 (see, e.g., FIGS. 36and 41) of each of the first and second films 342, 348 that will contactthe caplet 10. In addition, like the gelcaps 122, 214, 286 produced bythe first, second and third embodiments of the present invention, thegelcaps 404 produced by the vacuum forming apparatus 292 and method ofthe fourth embodiment are bi-colored, or have at least two visuallydistinct regions, having a film seam 410 between the film coatings thatlies substantially in the transverse plane of symmetry 16 of the core10, and a color transition 412 between the colors, or other visuallydistinct regions, that lies substantially in the conjugate plane ofsymmetry 18 of the core 10. In addition, the color transition 412 of thegelcap 404 may be flush and seamless, i.e., without any raised portionwhich generally characterizes the film seam 410. In addition, theforegoing process results in gelcap products 404 having a film coatingof uniform color quality and thickness over their entire surface. Ifaesthetically desired, the first and second films 342, 348 may beapplied to the core 10 such that the resulting gelcaps 404 have a filmseam 410 wherein a stripe of one color or visual distinction (forexample, a red stripe) of one film 342 abuts or overlaps a stripe ofanother color or visual distinction (for example, a yellow stripe) ofthe other film 348 to form a gelcap 404 having a “checkerboard pattern”(not shown), i.e., having four quadrants of alternating red and yellowcolors or other visual distinctions.

[0208] Although not shown in figures, an alternative to the apparatusand method of the fourth embodiment will now be described. Thealternative apparatus would include platens having recesses that areeach be circumscribed by a raised cutting ridge capable of cleanlycutting the first and second films 342, 348. In a further alternativemethod that may be practiced with the aforesaid apparatus, instead offirst placing the caplet 10 into the recess 310 of the first platen 294,the first film 342 would be laid across a first platen and then warm airwould be blown onto the first film 342 to soften it to a formable state.Then, a vacuum would be applied through the platen to pull the firstfilm 342 into the recess and conform it thereto. Thereafter, the core 10would be placed into the recess 310 and cool air blown onto the platen294, first film 342 and core, to mold the first film 342 into conformitywith the core 10. The second film 348 would then be placed onto theplaten, on top of the core 10, and warm air blown onto the second film348 to soften it to a formable state. Another platen (not shown) wouldthen be moved into contact with the second film 348, pressing the secondfilm 348 against the core 10 and the first platen 294, thereby,conforming the second film 348 to the contour of the caplet 10. Cool airis then blown onto the second film 348, thereby molding the second film348 onto the caplet 10. It is noted that the hot and cold airtemperature ranges, as well as the vacuum pressure range, are the sameas previously stated hereinabove in connection with the description ofthe fourth embodiment of the present invention. Lastly, the raisedcutting edges of the recesses cut through both of the first and secondfilms 342, 348, thereby releasing enrobed gelcap products each of whichhave a film seam that is transverse to the color transition (or visualdistinction transition) of the gelcaps.

[0209] The cores 10 that are suitable for use with the apparatus andmethods of the present invention are mass produced and well-known bythose having ordinary skill in the art. The cores enrobed with the filmof the present invention may contain one or more active agents. The term“active agent” is used herein in a broad sense and may encompass anymaterial that can be carried by or entrained in the system. For example,the active agent can be a pharmaceutical, nutraceutical, vitamin,dietary supplement, nutrient, oral care agent, herb, foodstuff,dyestuff, nutritional, mineral, supplement, or favoring agent or thelike and combinations thereof.

[0210] Suitable pharmaceuticals include analgesics, anti-inflammatoryagents, antiarthritics, anesthetics, antihistamines, antitussives,antibiotics, anti-infective agents, antivirals, anticoagulants,antidepressants, antidiabetic agents, antiemetics, antiflatulents,antifungals, antispasmodics, appetite suppressants, bronchodilators,cardiovascular agents, central nervous system agents, central nervoussystem stimulants, decongestants, diuretics, expectorants,gastrointestinal agents, migraine preparations, motion sicknessproducts, mucolytics, muscle relaxants, osteoporosis preparations,polydimethylsiloxanes, respiratory agents, sleep-aids, urinary tractagents and mixtures thereof.

[0211] Suitable oral care agents include breath fresheners, toothwhiteners, antimicrobial agents, tooth mineralizers, tooth decayinhibitors, topical anesthetics, mucoprotectants, and the like.

[0212] Suitable flavorants include menthol, peppermint, mint flavors,fruit flavors, chocolate, vanilla, bubblegum flavors, coffee flavors,liqueur flavors and combinations and the like.

[0213] Examples of suitable gastrointestinal agents include antacidssuch as calcium carbonate, magnesium hydroxide, magnesium oxide,magnesium carbonate, aluminum hydroxide, sodium bicarbonate,dihydroxyaluminum sodium carbonate; stimulant laxatives, such asbisacodyl, cascara sagrada, danthron, senna, phenolphthalein, aloe,castor oil, ricinoleic acid, and dehydrocholic acid, and mixturesthereof; H2 receptor antagonists, such as famotadine, ranitidine,cimetadine, nizatidine; proton pump inhibitors such as omeprazole orlansoprazole; gastrointestinal cytoprotectives, such as sucraflate andmisoprostol; gastrointestinal prokinetics, such as prucalopride,antibiotics for H. pylori, such as clarithromycin, amoxicillin,tetracycline, and metronidazole; antidiarrheals, such as diphenoxylateand loperamide; glycopyrrolate; antiemetics, such as ondansetron,analgesics, such as mesalamine.

[0214] In one embodiment, the active agent may be selected frombisacodyl, famotadine, ranitidine, cimetidine, prucalopride,diphenoxylate, loperamide, lactase, mesalamine, bismuth, antacids, andpharmaceutically acceptable salts, esters, isomers, and mixturesthereof.

[0215] In another embodiment, the active agent may be selected fromacetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen,flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib,celecoxib, and pharmaceutically acceptable salts, esters, isomers, andmixtures thereof.

[0216] In another embodiment, the active agent may be selected frompseudoephedrine, phenylpropanolamine, chlorpheniramine,dextromethorphan, diphenhydramine, astemizole, terfenadine,fexofenadine, loratadine, cetirizine, mixtures thereof andpharmaceutically acceptable salts, esters, isomers, and mixturesthereof.

[0217] Examples of suitable polydimethylsiloxanes, which include, butare not limited to dimethicone and simethicone, are those disclosed inU.S. Pat. Nos. 4,906,478, 5,275,822, and 6,103,260, the contents of eachis expressly incorporated herein by reference. As used herein, the term“simethicone” refers to the broader class of polydimethylsiloxanes,including but not limited to simethicone and dimethicone.

[0218] The active ingredient(s) is present in the dosage form in atherapeutically effective amount, which is an amount that produces thedesired therapeutic response upon oral administration and can be readilydetermined by one skilled in the art. In determining such amounts, theparticular active ingredient being administered, the bioavailabilitycharacteristics of the active ingredient, the dose regime, the age andweight of the patient, and other factors must be considered, as known inthe art. Preferably, the dosage form comprises at least about 85 weightpercent of the active ingredient. In one preferred embodiment, the corecomprises at least about 85 weight percent of the active ingredient.

[0219] If the active ingredient has an objectionable taste, and thedosage form is intended to be chewed or disintegrated in the mouth priorto swallowing, the active ingredient may be coated with a taste maskingcoating, as known in the art. Examples of suitable taste maskingcoatings are described in U.S. Pat. No. 4,851,226, U.S. Pat. No.5,075,114, and U.S. Pat. No. 5,489,436. Commercially available tastemasked active ingredients may also be employed. For example,acetaminophen particles which are encapsulated with ethylcellulose orother polymers by a coaccervation process may be used in the presentinvention. Coaccervation-encapsulated acetaminophen may be purchasedcommercially from Eurand America, Inc. Vandalia, Ohio, or from CircaInc., Dayton, Ohio.

[0220] Suitable excipients include fillers, binders, disintegrants,lubricants, glidants, and the like.

[0221] Suitable fillers include water-soluble compressible carbohydratessuch as sugars, which include dextrose, sucrose, maltose, and lactose,sugar-alcohols, which include mannitol, sorbitol, maltitol, xylitol,starch hydrolysates, which include dextrins, and maltodextrins, and thelike, water insoluble plasticly deforming materials such asmicrocrystalline cellulose or other cellulosic derivatives,water-insoluble brittle fracture materials such as dicalcium phosphate,tricalcium phosphate and the like and mixtures thereof.

[0222] Suitable binders include dry binders such as polyvinylpyrrolidone, hydroxypropylmethylcellulose, and the like; wet binderssuch as water-soluble polymers, including hydrocolloids such asalginates, agar, guar gum, locust bean, carrageenan, tara, gum arabic,tragacanth, pectin, xanthan, gellan, maltodextrin, galactomannan,pusstulan, laminarin, scleroglucan, gum arabic, inulin, pectin, whelan,rhamsan, zooglan, methylan, chitin, cyclodextrin, chitosan, polyvinylpyrrolidone, cellulosics, starches, and the like; and derivatives andmixtures thereof.

[0223] Suitable disintegrants include sodium starch glycolate,cross-linked polyvinylpyrrolidone, cross-linked carboxymethylcellulose,starches, microcrystalline cellulose, and the like.

[0224] Suitable lubricants include long chain fatty acids and theirsalts, such as magnesium stearate and stearic acid, talc, and waxes.Suitable glidants include colloidal silicon dioxide, and the like.

[0225] The dosage form of this invention may also incorporatepharmaceutically acceptable adjuvants, including, for example,preservatives, sweeteners such as aspartame, acesulfame potassium,sucralose, and saccharin; flavors, antioxidants, surfactants, andcoloring agents.

[0226] In one embodiment, the dosage forms comprising cores enrobed withthe films of the present invention provided for immediate release of theactive ingredient, i.e. the dissolution of the dosage form conformed toUSP specifications for immediate release tablets containing theparticular active ingredient employed. For example, for acetaminophentablets, USP 24 specifies that in pH 5.8 phosphate buffer, using USPapparatus 2 (paddles) at 50 rpm, at least 80% of the acetaminophencontained in the dosage form is released therefrom within 30 minutesafter dosing, and for ibuprofen tablets, USP 24 specifies that in pH 7.2phosphate buffer, using USP apparatus 2 (paddles) at 50 rpm, at least80% of the ibuprofen contained in the dosage form is released therefromwithin 60 minutes after dosing. See USP 24, 2000 Version, 19-20 and 856(1999).

[0227] It will be understood that the embodiments described hereinaboveare merely exemplary and that a person skilled in the art may make manyvariations and modifications without departing from the spirit and scopeof the present invention. All such variations and modifications areintended to be included within the scope of the invention.

I claim:
 1. A process enrobing a core comprising the steps of: providinga coating formed from at least one film having a transition line segmentbetween visually distinct portions thereof; and covering at least aportion of an outer surface of the core with said at least one film suchthat a film seam is formed which lies substantially in a first referenceplane, which passes through the core, and such that said transition linesegment lies substantially in a second reference plane, which passesthrough the core and intersects said first reference plane.
 2. Theprocess according to claim 1, wherein said at least one film includes afirst film having a first transition line segment between visuallydistinct portions thereof and a second film having a second transitionline segment between visually distinct portions thereof.
 3. The processaccording to claim 2, further comprising the steps of: covering a firstportion of said outer surface of the core with said first film such thatsaid first transition line segment lies substantially in said secondreference plane; and covering a second portion of said outer surface ofthe core with said second film such that said second transition linesegment lies substantially in said second reference plane.
 4. Theprocess according to claim 3, wherein said first and second transitionline segments cooperate to form a transition line on said coating. 5.The process according to claim 4, wherein said first film has a firstportion lying on one side of said first transition line segment and asecond portion lying on an opposite side of said first transition linesegment, said first and second portions of said first film beingvisually distinct from each other, and said second film has a firstportion lying on one side of said second transition line segment and asecond portion lying on an opposite side of said second transition linesegment, said first and second portions of said second film beingvisually distinct from each other.
 6. The process according to claim 5,wherein said first portion of said first film has a first visualappearance, said second portion of said first film has a second visualappearance, said first portion of said second film has a third visualappearance and said second portion of said second film has a fourthvisual appearance.
 7. The process according to claim 6, wherein saidfirst visual appearance of said first portion of said first film issubstantially the same as said third visual appearance of said firstportion of said second film, and second visual appearance of said secondportion of said first film is substantially the same as said fourthvisual appearance of said second portion of said second film, said firstand third visual appearances being different from said second and fourthvisual appearances.
 8. The process according to claim 7, furthercomprising the step of: orienting said first and second films, prior tocovering the outer surface of the core, such that said first portions ofsaid first and second films lie on one side of said transition line ofsaid coating, whereby said first portions are adjacent to one anotherand positioned on opposite sides of said film seam, and said secondportions of said first and second films lie on an opposite side of saidtransition line of said coating, whereby said second portions areadjacent to one another and positioned on opposite sides of said filmseam.
 9. The process according to claim 8, wherein said first and thirdvisual appearances are characterized by a first color and said secondand fourth visual appearances are characterized by a second color thatis different from said first color, whereby said coating of the enrobedcore includes at least two differently colored portions.
 10. The processaccording to claim 7, further comprising the step of: orienting saidfirst and second films, prior to covering the outer surface of the core,such that said first portion of said first film and said second portionof said second film lie on one side of said transition line, wherebysaid first portion of said first film and said second portion of saidsecond film are adjacent to one another and positioned on opposite sidesof said film seam, and said second portion of said first film and saidfirst portion of said second film lie on an opposite side of saidtransition line, whereby said second portion of said first film and saidfirst portion of said second film are adjacent to one another andpositioned on opposite sides of said film seam.
 11. The processaccording to claim 10, wherein said first and second visual appearancesare characterized by a first color and said second and fourth visualappearances are characterized by a second color that is different fromsaid first color, whereby said coating of the enrobed core includes atleast four colored portions that are alternately arranged on saidcoating.
 12. The process according to claim 3, wherein each of saidfirst and second films includes free edges.
 13. The process according toclaim 12, wherein said free edges are slightly spaced apart from oneanother, thereby forming said film seam of said coating.
 14. The processaccording to claim 12, further comprising the step of: sealing said freeedges of said first and second films together, thereby forming said filmseam of said coating.
 15. The process according to claim 14, whereinsaid free edges of said first and second films abut one another to formsaid film seam of said coating.
 16. The process according to claim 14,wherein said free edges of said first and second films overlap with oneanother to form said film seam of said coating.
 17. The processaccording to claim 3, wherein said transition line of said coating iscurvilinear.
 18. The process according to claim 1, wherein saidtransition line segment is curvilinear.
 19. The process according toclaim 1, wherein the core is a tablet.